The Recall Desk

Archive

October 2021 recalls

518 recalls were announced in October 2021.

What the numbers show

Critical
5
Severe
95
High
283
Moderate
132
Low
3

Of the 518 recalls this month scored against our rubric, 1% are Critical, 18% are Severe.

Which agencies issued them

401–500 of 518

  • HighFDA (Devices)·Z-2615-2021·2021-10-06

    Cardiosave Hybrid IABP may unexpectedly shut down on AC power

    The Cardiosave Hybrid Intra-Aortic Balloon Pump may unexpectedly shut down when running on AC power with one battery installed and the battery removed during charging. No injuries have been reported.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2546-2021·2021-10-06

    Outlook Pump IV Sets Recalled for Leakage and Infection Risk

    B. Braun Medical, Inc. is recalling approximately 44,866 Outlook Pump IV sets due to leakage of the pump set that could delay medication administration and increase the risk of bloodstream infections. The defect may result in under-delivery or incomplete medication dosing.

    Product
    Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2021·2021-10-06

    NAMIC Angiographic Manifolds Recalled for Potential Sterile Barrier Compromise

    Medline Industries recalled 816,420 NAMIC Angiographic Manifolds due to potential microscopic pinholes in sterile pouches that could compromise device sterility. No injuries reported.

    Product
    NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1022-2021·2021-10-06

    Little Debbie Mini Nutty Buddy Cookie Bites Undeclared Tree Nut Allergen

    Mckee Foods Corporation is recalling Little Debbie Mini Nutty Buddy Cookie Bites Sandwich Cookies due to an undeclared tree nut allergen that poses a risk to consumers with tree nut allergies.

    Product
    Little Debbie Mini Nutty Buddy Cookie Bites Sandwich Cookies 2.5oz plastic packaging 72 pouches per case
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1019-2021·2021-10-06

    Enrico Biscotti Anise Almond Biscotti Recalled for Undeclared Soy

    The Enrico Biscotti Company is recalling Enrico Biscotti Anise Almond Biscotti 8-ounce bags because they contain undeclared soy, a major allergen. The recall affects 3,840 bags distributed to Ohio and New York.

    Product
    Enrico Biscotti - Anise Almond Biscotti 8 ounce bags 6 bags per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2561-2021·2021-10-06

    Fluid management system control unit display freeze during hysteroscopic procedures

    A software defect in the Covidien HysteroLux fluid management system causes the display to freeze at a specific volume threshold during hysteroscopic surgery, creating risk of improper fluid accounting and potential circulatory complications.

    Product
    Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2596-2021·2021-10-06

    GE Healthcare anesthesia machine flow sensors may over-deliver anesthetic

    Flow sensors in GE Healthcare anesthesia machines built before June 2021 may have damaged tubing that leaks, potentially causing over-delivery of anesthetic to patients.

    Product
    Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2578-2021·2021-10-06

    Aesculap PAS-PORT Surgical Implant Recalled for Deployment Failure

    Aesculap Implant Systems is recalling 80 units of the PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM because the implant may fail to deploy during surgery, potentially requiring additional medical intervention.

    Product
    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2605-2021·2021-10-06

    Corin Trinity-i Acetabular Components Recalled Due to Packaging Damage

    Corin Ltd is recalling Corin Trinity-i acetabular components (50mm diameter, Taper Size 3) distributed nationwide due to potential physical and water damage to the packaging system, which may compromise device sterility or cause contamination.

    Product
    Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0007-2022·2021-10-06

    Driscoll's Blueberries Recalled for Potential Metal Pellets

    Driscoll's Only the Finest Berries Blueberries in 6 oz. and 1 pt. containers from Peru are being recalled due to potential metal pellets contamination. Affected products were distributed in the USA, Canada, and the Middle East.

    Product
    Driscoll's Only the Finest Berries - Blueberries/ Bluets 6 oz. and 1 pt. plastic clamshell containers. Product of Peru
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1025-2021·2021-10-06

    De Wafelbakkers Buttermilk Pancakes Recalled for Listeria Contamination

    De Wafelbakkers 18 ct Buttermilk Pancakes are being recalled nationwide because they may contain Listeria monocytogenes. Consumers should not eat the product.

    Product
    De Wafelbakkers 18 ct Buttermilk Pancakes NET WT 1 lb. 8.7 oz. (703g) KEEP FROZEN packaged in clear flexible plastic UPC 679844104573
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1018-2021·2021-10-06

    Enrico Biscotti Cranberry Pistachio Biscotti recalled for undeclared soy

    The Enrico Biscotti Company is recalling Enrico Biscotti Cranberry Pistachio Biscotti because the product contains undeclared soy, which poses a risk to consumers with soy allergies.

    Product
    Enrico Biscotti - Cranberry Pistachio Biscotti 8 ounce bags 6 bags per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1026-2021·2021-10-06

    Grab & Go Bistro Pimento Cheese Sandwich Recalled for Undeclared Fish Allergen

    Modern Distributors, Inc. is recalling Grab & Go Bistro Pimento Cheese Sandwiches because they contain fish that is not declared on the label. The product was distributed through vending machines in Kentucky.

    Product
    Grab & Go Bistro Pimento Cheese Sandwich 5oz plastic container 1 sandwich per package
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2611-2021·2021-10-06

    Corin Unity Knee Implant Components Recalled for Packaging Damage Risk

    Corin Ltd recalls two models of Unity Knee CS Insert implant components due to potential packaging damage that could compromise sterility or cause contamination. Affected devices were distributed in nine U.S. states in July 2021.

    Product
    Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243, Sterile, both are components of the Unity Total Knee System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2585-2021·2021-10-06

    Operating Room Table Rotational Lock May Fail to Function

    Deerfield Imaging operating room tables (ORT200/300) may have a mechanical defect in the rotational lock, preventing it from changing between locked and unlocked states. This could affect patient positioning during procedures.

    Product
    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2588-2021·2021-10-06

    Arjo Citadel Beds: Power Cord Wear May Cause Electrical Hazard

    Certain Arjo Citadel medical beds with IndiGo power cords may develop wear during normal use, potentially causing electrical short circuits and fire hazards. Units manufactured from May 2018 through February 2021 are affected.

    Product
    Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules asse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2600-2021·2021-10-06

    Patient Lift Device Stretch Leveller May Lose Horizontal Position Control

    Hill-Rom LikoStretch 1900 patient lift devices may lose their ability to maintain horizontal position during lifting, risking patient falls. Affected devices can cause patients to slide out of the lift sheet.

    Product
    LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2610-2021·2021-10-06

    Corin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss

    Corin Ltd is recalling Corin Unity knee implant augments because packaging damage could compromise device sterility and allow contamination. Affected units were distributed in 9 states during July 2021.

    Product
    Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2599-2021·2021-10-06

    Stretch Leveller Model 3156200 May Lose Horizontal Position Control

    Hill-Rom's Stretch Leveller Model 3156200 may lose the ability to maintain patients in a horizontal position during lifting, potentially causing patients to slide backward or fall from the lift sheet.

    Product
    Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2543-2021·2021-10-06

    Carotid and Gelsoft vascular patches recalled for incorrect instructions

    Vascutek vascular patches were distributed with rest-of-world instructions instead of U.S. instructions. The 159 units distributed to Puerto Rico and Guam have incorrect Instructions for Use for U.S. use.

    Product
    The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2616-2021·2021-10-06

    Cardiosave Rescue IABP may unexpectedly shut down during operation

    Datascope Corp. is recalling the Cardiosave Rescue IABP (models 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85) because the device may unexpectedly shut down when run on AC power with a single battery installed and that battery is removed during charging.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2021·2021-10-06

    Outlook V1500HP Pump Set Recalled for Cassette Leakage

    The Outlook V1500HP Pump Set is recalled due to cassette leakage that could delay medication delivery, reduce dosing accuracy, and cause bloodstream infections. The recall involves 12,000 units distributed in the US and Canada.

    Product
    V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2554-2021·2021-10-06

    Outlook Pump IV Set Recalled Due to Cassette Leakage and Infection Risk

    B. Braun Medical is recalling Outlook Pump IV Sets due to cassette leakage that may delay medication delivery and cause incomplete dosing or bloodstream infections.

    Product
    OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2598-2021·2021-10-06

    Medical Device: FlexoStretch Patient Lift Leveller May Lose Function During Patient Transfer

    Hill-Rom's FlexoStretch Model 3156057 patient lift device may lose the ability to maintain horizontal positioning during patient transfer, risking patient falls. The FDA Class II recall affects 129 units distributed worldwide.

    Product
    FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2021·2021-10-06

    Corin Trinity Liner hip implant components recalled due to packaging damage

    Corin Ltd is recalling specific Trinity Liner ECIMA hip implant components because packaging damage could compromise device sterility or cause contamination. Five units were distributed nationwide between July 22-26, 2021.

    Product
    Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both are components of the Trinity Acetabular System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2021·2021-10-06

    Corin Trinity Dual Mobility Hip Implant Components Recalled for Sterility Loss Risk

    Corin Ltd is recalling specific Trinity Dual Mobility hip implant components due to packaging damage that may compromise sterility. The affected products were distributed to medical facilities in nine states.

    Product
    Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head, REF 325.04.042, Sterile; both are components of the Trinity Dual Mobility System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2021·2021-10-06

    Radiation therapy planning software can save contours to wrong image set

    Elekta Monaco radiation therapy planning software has a defect allowing contour edits to be saved to the wrong image set without freezing the radiation dose for affected treatment plans.

    Product
    Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0876-2021·2021-10-06

    Washington Homeopathic Products Cistus Canadensis Drops Recall

    Washington Homeopathic Products is recalling Cistus Canadensis 5X Coldness 20% Alcohol drops (15ml and 50ml bottles) distributed nationwide due to out-of-specification identification test results.

    Product
    Cistus Canadensis 5X Coldness* 20% Alcohol drops, Packaged in a) 15ml; b) 50 ml; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0895-2021·2021-10-06

    Washington Homeopathic Products Aconitum Napellus 12X Fear Recall

    Washington Homeopathic Products is recalling Aconitum Napellus 12X Fear homeopathic medicine due to out-of-specification test results from identification testing.

    Product
    Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0835-2021·2021-10-06

    Neutrogena COOLDRY SPORT Sunscreen Spray Class II Recall

    Johnson & Johnson Consumer, Inc. is recalling 678,384 cans of Neutrogena COOLDRY SPORT sunscreen spray nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858, UPC 0 86800 10037 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0863-2021·2021-10-06

    Althaea Officinalis 4X Homeopathic Medicine Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Althaea Officinalis 4X, Iritable Bladder homeopathic medicine (Lot # 29377, Exp 8/17/2026) distributed nationwide because testing results failed to meet specifications for product identification.

    Product
    Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0874-2021·2021-10-06

    Althaea 6X Irritable Bladder Homeopathic Drops Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Althaea 6X Irritable Bladder drops (Lot #29377) distributed nationwide because identification testing via HPTLC analysis produced out-of-specification results.

    Product
    Althaea 6X, Iritable Bladder* 20% Alcohol, Drops, packaged as 15 ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0888-2021·2021-10-06

    ZTE 1015 Formula Homeopathic Product Recall for Out-of-Specification Test Results

    Washington Homeopathic Products is recalling ZTE 1015 Formula due to out-of-specification test results from identification testing. The product failed HPTLC analysis.

    Product
    ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Versicolor 10X, Lycopodium Clavatum 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0861-2021·2021-10-06

    Washington Homeopathic Products Haloderm Homeopathic Blend Recalled

    Washington Homeopathic Products is recalling Haloderm Homeopathic Blend due to out-of-specification test results from identification testing. The product was distributed nationwide.

    Product
    Haloderm Homeopathic Blend, For Manufacturing Use Only, 1,000 ml 20% Alcohol, Contains: Dulcamara 10x, Nitricum Acidum 12x, Thuja Occidentalis 10x, Antimonium Crudum 12x, Calcarea Cadbonica 12x, Silicea 12x, WHP Homeopathic Medicine, FOr Manufacturing Use Only. 1.957 kg Lactose
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0836-2021·2021-10-06

    Neutrogena Ultra Sheer Sunscreen Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 30 due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 1.6 million cans distributed nationwide.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 10038 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0886-2021·2021-10-06

    ZTE-1035 Homeopathic Formula Recalled for Test Failures

    Washington Homeopathic Products is recalling ZTE-1035 Formula, an antimicrobial homeopathic combination product, due to out-of-specification test results for identification testing based on HPTLC analysis.

    Product
    ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista Tinctoria 10X, Phosphorus 10X, Arnica Montana 10X, Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberis Vulgaris 10X, Glycyrrhiz
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2572-2021·2021-10-06

    Olympus BF-1T180 Bronchovideoscope Reprocessing Instructions Updated

    Olympus Corporation is issuing updated reprocessing instructions for the BF-1T180 EVIS EXERA II Bronchovideoscope to comply with FDA 2015 guidance on medical device reprocessing validation.

    Product
    BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2568-2021·2021-10-06

    Olympus BF-P60 Bronchofiberscope Reprocessing Instructions Updated to Meet FDA Guidance

    Olympus Corporation has issued new, validated reprocessing instructions for the BF-P60 OES Bronchofiberscope to comply with FDA guidance. The recall affects 1,030 devices distributed nationwide and internationally.

    Product
    BF-P60 OES Bronchofiberscope, Model No. BF-P60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0872-2021·2021-10-06

    Althaea Officinalis Homeopathic Pills Recall Due to Failed Identity Testing

    Washington Homeopathic Products is recalling Althaea Officinalis 6X Irritable Bladder Sucrose/Lactose Pills distributed nationwide because test results failed to confirm the product's identity using HPTLC analysis.

    Product
    Althaea Officinalis 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0839-2021·2021-10-06

    Neutrogena Ultra Sheer Sunscreen Recalled for cGMP Deviations

    Johnson & Johnson Consumer is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 100+ nationwide due to manufacturing deviations. Approximately 3.98 million cans are affected.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (15%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08858, UPC 0 86800 10041 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0848-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Class II Drug Recall

    Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Beach Defense water+sun protection sunscreen spray SPF 70 due to cGMP (current Good Manufacturing Practice) deviations. Approximately 411,180 cans distributed nationwide are affected.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 UPC 0 86800 10048 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2617-2021·2021-10-06

    Xcela PICC catheter mislabeled with incorrect size designation

    Angiodynamics is recalling Xcela PICC catheters where units labeled as 5F are actually 4F. The labeling discrepancy between labeled and actual product size could affect clinical device selection.

    Product
    Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0850-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 60+) due to current good manufacturing practice (cGMP) deviations. The recall is voluntary and affects nationwide distribution in the US.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2571-2021·2021-10-06

    BF-P180 EVIS EXERA II Bronchovideoscope Reprocessing Instructions Validation Recall

    Olympus Corporation issued updated reprocessing instructions for 1,177 BF-P180 EVIS EXERA II Bronchovideoscopes to ensure compliance with FDA validation standards for medical device sterilization.

    Product
    BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0851-2021·2021-10-06

    Lyrica CR 330 mg Tablets Recalled for Failed Dissolution

    Viatris is recalling Lyrica CR (pregabalin) 330 mg extended-release tablets nationwide due to failed dissolution specifications that may reduce drug effectiveness.

    Product
    Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1024-2021·2021-10-06

    Crunchy Cones ice cream recalled for undeclared sulfites

    Borinquen Cones of Puerto Rico is recalling Crunchy Cones Mix Choco-Vanilla because the product label does not declare the presence of sulfites, which may pose a risk to consumers with sulfite sensitivity.

    Product
    Crunchy Cones, Mix Choco-Vanilla, 12, NET WT 40oz (113g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0868-2021·2021-10-06

    Verbena Officinalis Homeopathic Pills Fail Identification Testing

    Washington Homeopathic Products is recalling 3 bottles of Verbena Officinalis 6X (Lot #29060, expiration 8/17/2026) distributed nationwide due to out-of-specification test results in identification testing.

    Product
    Verbena Officinalis 6X, Nervousness* Sucrose/Lactose Pills, Packaged 2 Dram, WHP Homeopathic Medicine, Washington Hoemopathis Producs, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0885-2021·2021-10-06

    ZTE-1034 Formula Antimicrobial Bowel homeopathic medicine recall

    Washington Homeopathic Products, Inc. is recalling ZTE-1034 Formula Antimicrobial Bowel (1000ml bottles) due to out-of-specification test results in identification testing. The product was distributed nationwide.

    Product
    ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Arsenicum Album 10X, Baptisia Tinctoria 10X, Pulsatilla 10X, Lachesis Mutus 11X, Rhus Toxicodendron 10X, Belladonna 7X, Colchicum Autumnale 5X, Aconitum Napellus 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0873-2021·2021-10-06

    Washington Homeopathic Products Althaea 6X Bladder Pills Recalled

    Washington Homeopathic Products is recalling Althaea 6X Irritable Bladder Pills due to out-of-specification test results from identification testing. Ten bottles nationwide have been affected.

    Product
    Althaea 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 1 OZ, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0833-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer is recalling Neutrogena Beach Defense water + sun protection sunscreen spray in two sizes (6.5 oz and 8.5 oz) nationwide due to current good manufacturing practice (cGMP) deviations.

    Product
    Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) NET WT. 6.5 OZ (184 g) (UPC 0 86800 87273 3) and b) NET WT. 8.5 oz (240 g) (UPC 0 86800 10032 4) aerosol can, Distributed
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2485-2021·2021-10-06

    Blood collection tubes recalled due to potential clotting defect

    Greiner Bio-One North America is recalling VACUETTE blood collection tubes (6 ml K2E) because they may experience a clotting issue. Approximately 962,400 tubes were distributed across 15 US states and Canada.

    Product
    VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2593-2021·2021-10-06

    uMI 550 PET Imaging System Software Workflow May Occasionally Freeze

    The uMI 550 medical imaging system may occasionally freeze during the EXAM acquisition workflow when a PET scan is canceled. This can disrupt clinical operations.

    Product
    uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1020-2021·2021-10-06

    Ferretts IPS Iron Liquid Dietary Supplement Stability Recall

    Monarch PCM, LLC is recalling Ferretts IPS Iron Liquid Dietary Supplement because stability testing shows the product degraded to 81% potency over a 3-month period, falling below specification limits.

    Product
    Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PET 24/410 bottle
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1023-2021·2021-10-06

    Crunchy Cones Chocolate recalled for undeclared sulfites

    Borinquen Cones of Puerto Rico is recalling Crunchy Cones Chocolate (12-count, 40oz boxes, Lot 24521) because the product label does not declare the presence of sulfites.

    Product
    Crunchy Cones, Chocolate, 12, NET WT 40oz (113g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1021-2021·2021-10-06

    HEB Jumbo Stuffed Shells Recalled for Possible Metal Contamination

    HEB Jumbo Stuffed Shells filled with ricotta and romano cheese may contain metal fragments. The product was distributed in Texas under item number 796702 with a sell-by date of 07/27/2022.

    Product
    HEB Jumbo Stuffed Shells; Jumbo Shells Filled with Creamy Ricotta and Romano Cheese; NET WT. 22 OZ (1 LB 6OZ) 624g
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0008-2022·2021-10-06

    RC Cola 12 oz cans recalled for off flavor and aroma

    Keurig Dr Pepper is recalling RC Cola 12 oz aluminum cans (12-pack) due to consumer complaints of off flavor and aroma. The affected product was distributed to multiple states.

    Product
    Rc Cola 12 Oz (355 mL) packaged in an aluminum can 12 can to a pack
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0859-2021·2021-10-06

    Washington Homeopathic Products Occular Allergy Blend fails identification testing

    Washington Homeopathic Products is recalling Occular Allergy Blend 87% Alcohol (Lot # 30148, 500 mL bottles) distributed nationwide due to out-of-specification test results in identification testing.

    Product
    Occular Allergy Blend 87% Alcohol; In Equal Parts of Apis Mellifica 7x Allium Cepa 7x Euphrasia Officinalis 7X Sabadilla 7X, WHP Homeopathic Medicine For Manufacturing Only, 500 ml. Manufcatured by Washington Homeopathic Products 260JR Hawvermale Way, Berkeley Springs WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0843-2021·2021-10-06

    Neutrogena Invisible Daily Defense Body Spray Sunscreen Recall

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Invisible Daily Defense body spray sunscreen (SPF 60+) due to cGMP deviations. The recall affects approximately 88,380 cans distributed nationwide.

    Product
    Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ. (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11154 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0892-2021·2021-10-06

    Aconitum Napellus Homeopathic Pills Fail Quality Test

    Washington Homeopathic Products is recalling Aconitum napellus Fear pills in multiple potencies nationwide due to failed identification testing by high-performance thin-layer chromatography (HPTLC).

    Product
    Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 5X, 6X,15X, packaged in 1 oz containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 7X, 12X, packaged in 2 dr containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 12X, 20X, packaged in 2 oz containers, Aconitum
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0849-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 50, 6.5 oz aerosol) distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall is voluntary and initiated by the firm.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0858-2021·2021-10-06

    ZTE-105 Formula Gentle Detoxing Recall Due to Failed Identification Testing

    Washington Homeopathic Products is recalling ZTE-105 Formula Gentle Detoxing due to out-of-specification test results from identification testing. The product was distributed nationwide.

    Product
    ZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Alba 10X, Chelidonium Majus 10X, Carduus Marianus 10X, Dolichos Pruriens 10X, Solidago Vigaurea 10X, Alfalfa 10X, Boldo 10X, Cynara Scolymus 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0841-2021·2021-10-06

    Neutrogena Beach Defense SPF 100 sunscreen spray recalled for cGMP deviations

    Johnson & Johnson is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 100, 6.5 oz aerosol cans) nationwide due to cGMP manufacturing deviations. The recall was voluntarily initiated by the company.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%), NET WT. 6.5 OZ (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, U
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0834-2021·2021-10-06

    Johnson & Johnson Neutrogena COOLDRY SPORT Sunscreen Spray Recalled

    Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena COOLDRY SPORT sunscreen spray (SPF 50) due to cGMP deviations. Approximately 867,816 cans distributed nationwide are affected.

    Product
    Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10036 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0837-2021·2021-10-06

    Neutrogena Ultra Sheer Sunscreen Body Mist Recalled for cGMP Deviations

    Johnson & Johnson Consumer is recalling Neutrogena Ultra Sheer body mist sunscreen in 5 oz and 8 oz aerosol cans nationwide due to current good manufacturing practice (cGMP) deviations. The recall is voluntary and initiated by the firm.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), a) Net Wt. 5 OZ (141 g) (UPC 0 86800 10039 3) and b) Net Wt. 8.0 oz. (226 g) (UPC 0 86800 11134 4) aerosol can, Distributed by: JOHNSON & JOHNS
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2021·2021-10-06

    Neutrogena COOLDRY SPORT Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY (5.5 oz, SPF 50) due to cGMP (current Good Manufacturing Practice) deviations. Approximately 1.4 million cans distributed nationwide are affected.

    Product
    Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%, Homosalate 5%, Octisalate 4.5%, Octocrylene 6%, Oxybenzone 4.5%. NET WT. 5.5 OZ. (155 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0887-2021·2021-10-06

    ZTE 1013 Formula Antimicrobial Homeopathic Product Recall

    Washington Homeopathic Products is recalling ZTE 1013 Formula Antimicrobial (1000 ml, Lot # 25738) distributed nationwide because testing identified out-of-specification results during identification analysis.

    Product
    ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberus Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Chromium Sulphuricum 10X, Manganum Metal
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0838-2021·2021-10-06

    Neutrogena Ultra Sheer Body Mist Sunscreen Recall for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 70 (5.0 oz aerosol cans) due to cGMP manufacturing deviations. The product was distributed nationwide.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10040 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0857-2021·2021-10-06

    Aconitum nap Fear Homeopathic Medicine Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Aconitum nap Fear homeopathic medicine nationwide due to out-of-specification test results from identification testing. The recall affects 562 bottles across multiple potencies and lot 26198.

    Product
    Aconitum nap Fear* 87% Alcohol HPUS: 5X, 7X, 18X, 30X, packaged in 30 mL containers, Aconitum nap Fear* 87% Alcohol HPUS: 24X, packaged in 50 mL containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0869-2021·2021-10-06

    Viola Odorata Homeopathic Medicine Recall for Failed Identification Testing

    Washington Homeopathic Products is recalling Viola Odorata homeopathic medicine (Lot #29057, expiration 8/17/2026) distributed nationwide because identification testing using HPTLC analysis returned out-of-specification results.

    Product
    Viola Odorata 4X, 10X, 12X, Bee Stings*, Sucrose/Lactose Pills, 4X Packaged in a) 2 Dram; 10X Packaged in b) 2 Dram; 12X Packaged in c) 2 Dram; d) 4 Dram; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0852-2021·2021-10-06

    Drug recall: Daytime/Nighttime Severe Cold & Flu Relief vials subpotent

    New Vision Pharmaceuticals is recalling Daytime and Nighttime Severe Cold & Flu Relief single-use vials because the drug is subpotent—meaning it contains less active ingredient than intended. The recall was initiated voluntarily on September 2, 2021.

    Product
    Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057
    Category
    Drug
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0883-2021·2021-10-06

    Z-1050 Formula Hepatodetox Homeopathic Medicine Fails Identification Testing

    Washington Homeopathic Products, Inc. is recalling Z-1050 Formula Hepatodetox 1000ml bottles because out-of-specification test results were obtained during identification testing based on HPTLC analysis.

    Product
    Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Cholesterinum 10X, Avena Sativa 12X, Cynara Scolymos 12X, Phosphorus 12X, Oroticum Acidum 13X, Aesculus Hipposcastanum 24X, Carduus Marianus 24X, Chelidonium Majus 24X, Cimi
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0846-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recall Due to cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 70) nationwide due to cGMP deviations. This is a voluntary recall initiated by the manufacturer.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), a) NET WT. 6.5 OZ. (184 g) (UPC 0 86800 87274 0) and b) NET WT. 8.5 OZ. (240 g) (UPC 0 86800 10048 5) aerosol can, Distribut
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0889-2021·2021-10-06

    Strophanthus Hisp 30X Homeopathic Medicine Fails Identification Test

    Washington Homeopathic Products is recalling 91 bottles of Strophanthus hisp 30X for Hives due to failed identification testing. The product did not meet specifications in HPTLC analysis and was distributed nationwide.

    Product
    Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 40640 47553 9; (b) 30mL UPC 7 40640 47557 7; (c) 100mL, UPC 7 40640 47565 2; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0867-2021·2021-10-06

    Quebracho Homeopathic Pills Fail Identification Testing

    Washington Homeopathic Products is recalling Quebracho homeopathic pills in multiple potencies because testing identified out-of-specification results during identification analysis.

    Product
    Quebracho 4C, 5C, 6C, 12C, 30C, Fever*, Sucrose/Lactose Pills, 5C Packaged as a) 4dr; 6C Packaged as b) 4 Dram UPC 7 40640 44092 6; c) 2 oz UPC 7 40640 44100 8; 12C Packaged as d) 4 Dram; e) 2 oz; 30C Packaged as f) 2 dr UPC 7 40640 44090 2; g) 4 Dram, UPC 7 40640 44094 0; h) 1 o
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0898-2021·2021-10-06

    Sodium Phenylbutyrate Powder Recalled for Impurity Specification Failures

    SigmaPharm Laboratories is recalling Sodium Phenylbutyrate Powder due to failed impurity and degradation specifications detected during routine testing. The affected lots are distributed nationwide.

    Product
    Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0847-2021·2021-10-06

    Neutrogena Ultra Sheer SPF 30 Body Mist Sunscreen Recall

    Johnson & Johnson Consumer, Inc. is recalling approximately 196,380 cans of Neutrogena Ultra Sheer body mist sunscreen SPF 30 nationwide due to cGMP deviations. This is a voluntary recall initiated by the manufacturer.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 8.0 oz. (226 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 11133 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0881-2021·2021-10-06

    ZTE-1020 Homeopathic Formula Recalled for Failed Identification Testing

    Washington Homeopathic Products, Inc. is recalling ZTE-1020 Formula (1000ml bottle, Lot #25740) distributed nationwide because identification testing based on HPTLC analysis produced out-of-specification results.

    Product
    ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Crataegus Oxyacantha 10X, Baryta Carbonica 10X, Digitalis Purpurea 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcoho
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0879-2021·2021-10-06

    Z-103 GU DETOXING Homeopathic Medicine Recall for Failed Identification Testing

    Washington Homeopathic Products is recalling Z-103 GU DETOXING, a 1000ml homeopathic medicine containing 20% alcohol, due to out-of-specification test results on identification testing using HPTLC analysis.

    Product
    Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For Manufacturing Use Only, REMEDY: Agrimonia Eupatoria 24X, Alfalfa 24X, Althaea Officinalis 24X, Avena Sativa 24X, Boldo 24X, Carduus Marianus 24X, Chioanathus Virginica 24X, Cynara Scolymus 24X, Iria Ver
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0880-2021·2021-10-06

    Z-107 Formula Soft Tissue Healing Recalled for Out-of-Specification Test Results

    Washington Homeopathic Products, Inc. is recalling Z-107 Formula Soft Tissue Healing due to out-of-specification test results from identification testing. The product was distributed nationwide.

    Product
    Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY: Amygdalus Persica 10X, Arnica Montana 10X, Bellis Perennis 10X, Chromium Sulphuricum 10X, Citrus Vulgaris 10X, Derris Pinnata 13X, Franciscea Uniflora 13X, Hamamelis Virginiana 10X, Manganum M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0864-2021·2021-10-06

    Washington Homeopathic Cinnamomum Pills Recalled for Failed Identity Testing

    Washington Homeopathic Products is recalling Cinnamomum 6X and 30X homeopathic pills due to failed identification testing results. The products did not meet specifications in HPTLC analysis.

    Product
    Cinnamomum 6X, Flatulence* Sucrose/Lactose Pills, Packaged as a) 4 Dram, b) 1 oz, and Cinnamomum 30X, Flatulence* Sucrose/Lactose Pills, Packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2570-2021·2021-10-06

    Olympus BF-XT160 Bronchovideoscope Reprocessing Instructions Updated for FDA Compliance

    Olympus Corporation is issuing updated reprocessing instructions for 293 BF-XT160 bronchovideoscopes to comply with FDA 2015 guidance. Healthcare facilities should implement the new sterilization and disinfection procedures.

    Product
    BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0871-2021·2021-10-06

    Washington Homeopathic Products Kali Sulphuricum fails identification test

    Washington Homeopathic Products is recalling Kali Sulphuricum 3X homeopathic medicine nationwide because identification testing using HPTLC analysis produced out-of-specification results.

    Product
    Kali Sulphuricum 3X, 960ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Use Only. Manufactured by Washington Homeopathic Products 260JR hawvermale Way Berkeley Springs WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2594-2021·2021-10-06

    uEXPLORER PET/CT System Workflow Freeze Recall

    The uEXPLORER PET/CT System is being recalled because the EXAM acquisition workflow may freeze after canceling a PET scan. Affected systems may experience workflow interruptions during diagnostic imaging.

    Product
    uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0832-2021·2021-10-06

    Neutrogena COOLDRY SPORT Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson is recalling Neutrogena COOLDRY SPORT sunscreen spray SPF 30 in two sizes nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 469,764 cans.

    Product
    Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) Net Wt 5.0 oz (141g) (UPC 0 86800 10035 5) and b) Net Wt. 8 oz. (226 g) UPC 0 86800 10031 7 aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC., Skill
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·22004·2021-10-06

    Hobby Lobby White Wood Stools Recalled for Fall and Injury Hazards

    Hobby Lobby is recalling about 14,000 White Wood Stools sold nationwide from June through July 2021 because the stools can break during use, posing fall and injury hazards. Hobby Lobby has received seven reports of the stool breaking, including six resulting in minor injuries.

    Product
    White Wood Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0862-2021·2021-10-06

    Cedar Fever Drops Homeopathic Drug Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Cedar Fever Drops due to out-of-specification test results from identification testing. The affected product was distributed nationwide.

    Product
    Cedar Fever Drops, 20% USP ALCOHOL, 30 mL, homeopathic drug for symptoms of cder allerges, Manufactured for Peoples RX, 3801 S Lamar, Austin, TX 78704. UPC 7 40640 64166 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0891-2021·2021-10-06

    Aconitum Napellus Fear Homeopathic Medicine Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling 562 bottles of Aconitum Napellus Fear homeopathic medicine nationwide due to out-of-specification test results from identification testing.

    Product
    Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X, packaged in 15mL containers, Aconitum Napellus Fear* 20% Alcohol HPUS: 6X, 10X, packaged in 30mL containers Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 10X, 12X, 30X, packaged in 50mL containers Aconitum Napellus Fear
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0854-2021·2021-10-06

    Valproic Acid Oral Solution Recalled for Microbial Contamination

    American Health Packaging is recalling Valproic Acid Oral Solution due to potential microbial contamination in liquid sugar batches used during manufacturing. The affected product was distributed nationwide.

    Product
    Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0865-2021·2021-10-06

    Washington Homeopathic Cistus Canadensis pills fail quality identification testing

    Washington Homeopathic Products is recalling Cistus Canadensis homeopathic pills in multiple potencies because they failed out-of-specification identification testing. The recall affects 17 bottles distributed nationwide.

    Product
    Cistus Canadensis 6X, 10X, 15X, 30X, Coldness* Sucrose/Lactose Pills, 6X Packaged as a) 1 OZ, UPC 7 40640 28177 2, b) 4 dr, UPC 7 40640 28173 4; 10X Packaged as c) 4 dr; 15X Packaged as d) 1 OZ; 30X Packaged as e) 2 Dram, UPC 7 40640 28171 0, f) 4 dr, UPC 7 40640 28175 8; WHP Hom
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0870-2021·2021-10-06

    Washington Homeopathic Products Homeopathic Medicine Fails Identity Testing

    Washington Homeopathic Products is recalling La Core LCL-2-0191 Blend homeopathic medicine due to out-of-specification test results in identification testing. The product was distributed nationwide.

    Product
    La Core LCL-2-0191 Blend, 149,980ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Only, Liter LCL-2-0191-Bend: 12% Lycopodium Clavatum 10X, 12% Carbo Vegetabilis 16X, 12% Natrum Muriaticum 9X, 12% Calcarea Carbonica 12X, 10% Hypothalamus 30X, 6% Pituitarum Posterium 12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0894-2021·2021-10-06

    Aconitum nap Fear Homeopathic Medicine Recalled for Failed Product Identification Testing

    Washington Homeopathic Products is recalling Aconitum nap Fear 20% Alcohol homeopathic medicine (Lot #26198) distributed nationwide due to out-of-specification test results from HPTLC identification analysis.

    Product
    Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers Aconitum nap Fear* 20% Alcohol HPUS: 7X, 12X, packaged in 15mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0890-2021·2021-10-06

    Strophanthus hisp 30X Homeopathic Hives Pills Recalled for Testing Failures

    Washington Homeopathic Products is recalling Strophanthus hisp 30X Hives pills after testing identified out-of-specification results in identification tests. The recall affects approximately 91 bottles distributed nationwide.

    Product
    Strophanthus hisp 30X, Hives*, Sucrose/Lactose Pills , Packaged in (a) 2 dr, UPC 7 40640 47533 1; (b) 4 dr UPC 7 40640 47537 9; (c) 1 oz, UPC 7 40640 47541 6; (d) 2 oz, UPC 7 40640 47545 4; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0860-2021·2021-10-06

    Yeast Guard Blend Homeopathic Medicine Fails Identification Testing

    Washington Homeopathic Products is recalling Yeast Guard Blend homeopathic medicine because test results show it does not meet specification requirements for identification testing.

    Product
    Yeast Guard Blend, Calcarea Carbonica 6X, Collinsonia Canadensis 3X, Kali Muriaicum 3X, WHP Homeopathic Medicine, For Manufacturing Use Only. 1.957 kg Lactose, Manufactured by Wasington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2021·2021-10-06

    Althaea 30X Homeopathic Pills Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Althaea 30X Irritable Bladder sucrose/lactose pills (Lot #29377, expiration 8/17/2026) distributed nationwide because testing revealed out-of-specification results for product identification.

    Product
    Althaea 30X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0855-2021·2021-10-06

    Hydroquinone 4% Skin Bleaching Cream Recalled for Specification Failure

    Monarch PCM, LLC is recalling Hydroquinone USP 4% Skin Bleaching Cream because the finished product did not meet USP (United States Pharmacopeia) specifications. The recall affects 11,419 tubes distributed in Tennessee.

    Product
    HYDROQUINONE — HYDROQUINONE (HYDROQUINONE)
    Category
    Drug
    Distribution
    1 state

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