The Recall Desk

Archive

February 2022 recalls

666 recalls were announced in February 2022.

What the numbers show

Critical
14
Severe
241
High
229
Moderate
176
Low
6

Of the 666 recalls this month scored against our rubric, 2% are Critical, 36% are Severe.

201–300 of 666

  • HighFDA (Food)·F-0635-2022·2022-02-16

    Natural Way Cheese Ranch Cheese Curds Recalled for Improper Milk Storage

    Natural Way Cheese is recalling Ranch Cheese Curds due to milk stored in a holding tank beyond the required 72-hour cleaning interval. The recalled products were distributed in Michigan and Indiana.

    Product
    Natural Way Cheese Ranch Cheese Curds, retail 12oz plastic bag UPC 8 10056 75014 5, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0733-2022·2022-02-16

    Fresh cheese recalled for potential coliform contamination

    Quesos La Ricura Mi Ranchito Fresh Cheese with Hot Peppers may contain elevated levels of coliform bacteria. Approximately 2,478 units were distributed across 11 states with a sell-by date of March 20, 2022.

    Product
    Quesos La Ricura Mi Ranchito Fresh Cheese with Hot Peppers, 14. 0z.
    Category
    Food
    Distribution
    10 states
  • HighCPSC·22083·2022-02-16

    Valco Baby Snap Duo Trend Strollers recalled for front wheel breakage hazard

    Valco Baby is recalling Snap Duo Trend strollers because the front wheels can break off during use, causing the stroller to fall unexpectedly. Consumers should stop using the stroller immediately and contact Valco Baby for a free replacement wheel assembly.

    Product
    Valco Baby Snap Duo Trend Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2022·2022-02-16

    Orthopedic knee replacement component recalled for adhesive residue contamination

    DePuy Orthopaedics is recalling 3 units of ATTUNE REVISION DISTAL FEMORAL AUGMENT due to adhesive residue that could cause tissue irritation or infection if not detected before surgery.

    Product
    ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2022·2022-02-16

    GE Healthcare MRI Cryogen Ventilation System Defect Recall

    GE Healthcare is recalling 17,228 MRI systems due to a potential defect in the cryogen ventilation system that may not meet venting requirements. This Class II recall affects systems distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V567000·2022-02-16

    2017-2021 Freightliner Cascadia Brake Lights May Remain Illuminated

    Daimler Trucks North America is recalling 2017-2021 Freightliner Cascadia trucks because brake lights may remain illuminated after braking. This increases crash risk by making drivers unaware of actual braking.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2022·2022-02-16

    GE Healthcare MRI Systems Cryogenic Ventilation System Failure Recall

    GE Healthcare is recalling 17,228 MR Vectra MRI systems because the cryogenic ventilation system may not meet required venting specifications.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2022·2022-02-16

    Baxter PD Transfer Sets may leak or crack from common cleaning products

    Certain cleaning products can damage Baxter MiniCap Extended Life PD Transfer Sets, causing them to leak or crack. Baxter is recalling approximately 61,290 units sold worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0609-2022·2022-02-16

    GE Healthcare 1.5T SIGNA MRI systems recalled for ventilation defect

    GE Healthcare is recalling 17,228 of its 1.5T SIGNA HDe MR imaging systems because the cryogenic ventilation system does not meet required venting standards.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2022·2022-02-16

    Baxter MiniCap PD Transfer Sets may leak or crack with certain cleaners

    Certain cleaning products can damage Baxter MiniCap PD Transfer Sets, potentially causing them to leak or crack. This could affect the safety of peritoneal dialysis treatment if the damaged set is used.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0587-2022·2022-02-16

    QC Control Materials KWIK-STIK AST-GP Produce Incorrect Test Results

    Microbiologics Inc recalls KWIK-STIK AST-GP quality control materials that produce incorrect antibiotic susceptibility test results. Two lot numbers were distributed worldwide.

    Product
    QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V090000·2022-02-16

    2022 Lucid Air suspension defect may cause brake failure and loss of control

    Lucid Motors is recalling certain 2022 Lucid Air vehicles due to a failing snap ring in the front strut damper. This defect may result in sudden loss of ride height or brake line damage, increasing the risk of a crash.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0620-2022·2022-02-16

    GE Healthcare Optima MR430s MRI systems have potential cryogenic ventilation defect

    GE Healthcare recalled MR430s MRI systems because the cryogenic ventilation system may not meet required venting standards, creating potential safety risks.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0600-2022·2022-02-16

    GE Healthcare MRI Systems Recalled for Cryogen Ventilation Issue

    GE Healthcare is recalling 17,228 SIGNA Artist MRI systems due to a potential defect in the cryogen ventilation system that may not meet safety venting requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2022·2022-02-16

    Baxter PD Transfer Sets Recalled Due to Chemical Damage Risk

    Baxter Healthcare is recalling approximately 58,194 units of its MiniCap Extended Life PD Transfer Sets distributed worldwide because certain cleaning products may damage the sets, causing leaking or cracking.

    Product
    Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0607-2022·2022-02-16

    GE Healthcare SIGNA MR Systems cryogenic ventilation system defect recall

    GE Healthcare recalled approximately 17,228 SIGNA MR magnetic resonance imaging systems because the cryogenic ventilation systems may not meet proper venting requirements. The defect could create potential safety hazards.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0603-2022·2022-02-16

    GE Healthcare MRI systems recalled for cryogen ventilation defect

    GE Healthcare is recalling certain MRI systems because the cryogen ventilation system does not meet venting requirements. The defect could affect safe operation of the MRI magnet.

    Product
    GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0619-2022·2022-02-16

    GE Healthcare MR superconducting magnets recalled due to cryogen ventilation system defect

    GE Healthcare has recalled 17,228 MR superconducting magnets used in nuclear magnetic resonance imaging systems because the cryogen ventilation system does not meet required venting standards. The recall affects devices distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0634-2022·2022-02-16

    Natural Way Cheese Horseradish Cheese Curds Recalled for Improper Milk Storage

    Natural Way Cheese is recalling Horseradish Cheese Curds because the milk used was stored in a tank beyond the required 72-hour cleaning interval, creating risk of bacterial contamination.

    Product
    Natural Way Cheese Horseradish Cheese Curds, retail 12oz plastic bag UPC 8 10056 75106 7, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·22V083000·2022-02-16

    2021-2022 Ford Mustang Front Passenger Knee Air Bag Weld Defect

    Ford is recalling 2021-2022 Mustang vehicles due to insufficient welds on the front passenger knee air bag, which could deploy improperly and increase injury risk during crashes. Affected owners should contact dealers for a free replacement.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2022·2022-02-16

    CURAD Reusable Gel Hot/Cold Pack Contains Undisclosed Natural Rubber Latex

    Medline Industries is recalling 494,273 CURAD Reusable Gel Hot/Cold Packs because the product contains natural rubber latex that is not disclosed on the label. Consumers with latex allergies face risk of allergic reaction.

    Product
    CURAD REUSABLE GEL HOT/COLD PACK
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0574-2022·2022-02-16

    Baxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Damage Risk

    Baxter is recalling 116,628 peritoneal dialysis transfer sets worldwide because certain cleaning chemicals can damage the device, potentially causing leaking or cracking.

    Product
    Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0614-2022·2022-02-16

    GE SIGNA MRI Systems Recalled for Cryogen Ventilation Defect

    GE Healthcare is recalling 17,228 MRI systems with a potential cryogen ventilation system defect that may not meet regulatory venting requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V084000·2022-02-16

    Audi Recalls 2022 E-Tron GT for Rear Seat Belt Wiring Issue

    Audi is recalling 2022 E-Tron GT vehicles because the center seat belt wiring harness may block access to child seat anchors, preventing proper securing.

    Product
    AUDI — AUDI E-TRON GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0566-2022·2022-02-16

    Avanos MIC Percutaneous Gastrostomy Kit Recalled for Bolster Sizing Defect

    Avanos Medical is recalling the MIC Percutaneous Endoscopic Gastrostomy PEG Kit because the external retention bolster may be larger than the tube, creating a risk of improper fit and potential device failure.

    Product
    MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2022·2022-02-16

    Baxter MiniCap PD Transfer Sets Recalled for Chemical Damage Risk

    Baxter Healthcare is recalling 2,553,528 units of the MiniCap Extended Life PD Transfer Set worldwide because cleaning products containing certain chemicals may cause the device to leak or crack.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0590-2022·2022-02-16

    GE Healthcare MRI Systems Cryogen Ventilation System Defect Recall

    GE Healthcare is recalling SIGNA Premier MRI systems due to a cryogen ventilation system that does not meet venting requirements. Approximately 17,228 affected devices were distributed worldwide.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0576-2022·2022-02-16

    Baxter PD Transfer Set Recall: Risk of Leaking or Cracking

    Baxter recalls 62,712 MiniCap Extended Life PD Transfer Sets worldwide due to potential damage from certain cleaning products. Exposure to products containing bleach, hydrogen peroxide, or solvents may cause leaking or cracking.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0592-2022·2022-02-16

    GE Healthcare MRI superconducting magnets recalled for improper cryogen venting

    GE Healthcare has recalled SIGNA Pioneer MRI systems due to potential cryogen ventilation defects that do not meet safety requirements. Approximately 17,228 devices are affected nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22081·2022-02-16

    American Landmaster Utility Vehicles Recalled for Steering Shaft Separation

    American Landmaster has recalled about 1,050 utility vehicles (EV, L3, L4, L5, L5W, and L7 models) because the steering shaft can separate from its joint, causing loss of control and crash hazards. Seven steering shaft separations have been reported with no injuries yet.

    Product
    American Landmaster EV, L3, L4, L5, L5W and L7 Utility Vehicles (UTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V086000·2022-02-16

    2019 Volkswagen Atlas: Missing GVWR Label on Side-Step Models

    Volkswagen is recalling certain 2018-2021 Atlas and Atlas Cross Sport vehicles equipped with side steps due to a missing GVWR label that reflects the additional weight, increasing overloading risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS, ATLAS CROSS SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0636-2022·2022-02-16

    Natural Way Cheese Curds Recalled for Improper Milk Storage

    Natural Way Cheese White Cheddar Cheese Curds are being recalled because milk used in the product exceeded the required 72-hour tank cleaning interval. Consumers should not consume this product.

    Product
    Natural Way Cheese White Cheddar Cheese Curds, retail 12oz plastic bag UPC 8 10056 75021 3, 12 retail units per wholesale case, and sold in 10lbs wholesale plastic bag as well
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0613-2022·2022-02-16

    GE MRI superconducting magnet systems recalled for cryogen ventilation system defect

    GE Healthcare is recalling 17,228 MR superconducting magnet systems due to a potential cryogen ventilation system that does not meet venting requirements. The defect could pose safety risks to healthcare facilities and their staff.

    Product
    GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0612-2022·2022-02-16

    GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defect

    GE Healthcare is recalling 17,228 MRI superconducting magnets that may have improper cryogen ventilation systems. The defect could fail to properly vent cryogenic materials in the SIGNA 3.0T MR System.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2022·2022-02-16

    QC Blood Culture Identification Panel Recall for Incorrect Antibiotic Susceptibility Test Results

    Microbiologics recalls KWIK-STIK blood culture identification quality control panels due to incorrect susceptibility test results. High-level Gentamicin Synergy values were out of specification, risking inaccurate diagnostic guidance.

    Product
    QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0585-2022·2022-02-16

    Quality Control Kit for Antibiotic Susceptibility Testing Returning Incorrect Results

    Microbiologics Inc is recalling KWIK-STIK quality control kits used by laboratories because certain lots return incorrect test results that could affect laboratory testing accuracy.

    Product
    KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V087000·2022-02-16

    Ford F-250 and F-350 Driveshaft Fracture Risk From Loose Insulators

    Ford is recalling 2017–2022 F-250 and F-350 Super Duty trucks. Underbody insulators may loosen and damage the aluminum driveshaft, potentially causing loss of drive power or vehicle control.

    Product
    FORD — FORD F-250 SD, F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0615-2022·2022-02-16

    GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect

    GE Healthcare MR superconducting magnets in SIGNA MRI systems may have cryogen ventilation systems that do not meet safety venting requirements. Approximately 17,228 systems are affected.

    Product
    GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0631-2022·2022-02-16

    Knee Replacement Component Recalled for Adhesive Residue Risk

    DePuy Orthopaedics is recalling ATTUNE Revision knee implant components due to possible adhesive residue on the surface. If undetected before surgery, the residue may cause soft tissue irritation or infection.

    Product
    ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0563-2022·2022-02-16

    Arterial Line Kits recalled due to guidewire-needle incompatibility

    Argon Medical Devices is recalling Arterial Line Kits because the included guidewires don't fit through the kit's needles. This could cause procedure delays and minor blood loss.

    Product
    1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0798-2022·2022-02-16

    Simply Good Proteins Collagen Powder Recalled for Undeclared Milk Allergen

    Naomi Whittel Brands is recalling Simply Good Proteins Collagen Protein Powder due to undeclared milk allergen. The recall affects online customers in the US who purchased the affected lot codes.

    Product
    Simply Good Proteins Collagen Protein Hydrolyzed Protein Powder 15g Protein NET WT. 15.5oz (.97lb) 440g . UPC code: 8 5782600866 2 Packed in HDPE Plastic. Simply Good Collagen Protein Hydrolyzed Protein Powder 25g Protein NET WT. 31.3oz (1.96lb) 888g UPC code: 8 57826008655 2…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0597-2022·2022-02-16

    GE Healthcare MRI Magnets Recalled for Inadequate Cryogen Ventilation

    GE Healthcare is recalling MRI magnets used in SIGNA MR355 and MR360 systems that could have cryogen ventilation systems not meeting venting requirements. These systems were distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0641-2022·2022-02-16

    Natural Way Cheese Sweet Basil Cheese Curds Recalled for Improper Milk Storage

    Natural Way Cheese is recalling Sweet Basil Cheese Curds because the milk used was stored in a holding tank for more than 72 hours, exceeding required cleaning intervals.

    Product
    Natural Way Cheese Sweet Basil Cheese Curds, retail 12oz plastic bag UPC 8 10056 75015 2, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • HighCPSC·22082·2022-02-16

    Viking 5 Series Freestanding Gas Ranges Recalled for Gas Leak and Fire Risk

    Viking Range is recalling about 3,050 Viking 5 Series freestanding gas ranges because the rigid gas tubing can separate at burner joints, creating a risk of gas leak and fire. Consumers should stop using the bake, broil, and griddle functions immediately and contact Viking for a free repair.

    Product
    Viking 5 Series Freestanding Gas Ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0588-2022·2022-02-16

    Diagnostic Quality Control Microorganism Set Fails Gentamicin Susceptibility Specifications

    Microbiologics Inc is recalling 139 units of KWIK-STIK AST-GP QC microorganism sets due to incorrect susceptibility test results. The products failed gentamicin synergy specifications and could affect the accuracy of laboratory diagnostic testing.

    Product
    QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2022·2022-02-16

    LYFO DISK Streptococcus Pneumoniae Culture Kit Recalled for Bacterial Contamination

    Microbiologics Inc is recalling LYFO DISK Streptococcus pneumoniae microorganism culture kits (lot 947-126-1) distributed worldwide due to potential contamination with E. coli, Staphylococcus epidermidis, and S. warneri.

    Product
    LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2022·2022-02-16

    GE Healthcare MRI Systems Recalled for Inadequate Cryogenic Ventilation

    GE Healthcare has recalled 17,228 MRI systems because the cryogenic ventilation system does not meet safety requirements. Systems were distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2022·2022-02-16

    GE Healthcare MRI Systems with Potentially Non-Compliant Cryogen Ventilation Systems

    GE Healthcare has recalled approximately 17,228 MRI systems due to cryogen ventilation systems that may not meet required venting standards. The issue affects systems distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2022·2022-02-16

    GE Healthcare MRI systems recalled for cryogenic ventilation defect

    GE Healthcare MRI systems may have cryogenic ventilation systems that do not meet venting requirements. The recall affects 17,228 devices distributed nationwide and globally. Healthcare facilities should contact GE Healthcare for corrective actions.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0800-2022·2022-02-16

    MCT Oil Powder Recalled for Undeclared Milk Allergen

    Simply Goodfats Creamy MCT Vanilla MCT Oil Powder is recalled due to undeclared milk allergen. The recall affects approximately 1,647 units distributed online in the US.

    Product
    Simply Goodfats Creamy MCT Vanilla MCT Oil Powder 10.5 OZ packaged White HDPE Plastic. UPC Code: 857826008648 Expiration dates: 8/31/2021 8/31/2022 2/28/2022
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0606-2022·2022-02-16

    GE Healthcare MRI Systems Recalled for Inadequate Cryogen Ventilation

    GE Healthcare SIGNA HFO/I MR Systems may have cryogen ventilation systems that do not meet venting requirements. Approximately 17,228 systems are affected nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2022·2022-02-16

    BD Veritor Plus Analyzer may overheat when using unauthorized power adapter

    BD Veritor Plus Analyzer devices may overheat or catch fire if powered with an unauthorized AC adapter instead of the manufacturer-provided one. The recall affects approximately 129,848 analyzers distributed worldwide.

    Product
    BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2022·2022-02-16

    Gentueri Viral Transport Medium Kit recalled due to sterility failure

    Gentueri Inc is recalling Viral Transport Medium Kits due to failed sterility testing and evidence of contamination. The recall affects 13,975 units distributed to Illinois, Nebraska, and Wisconsin.

    Product
    Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0608-2022·2022-02-16

    GE Healthcare MRI systems recalled over improper cryogen ventilation

    GE Healthcare is recalling MRI systems with potentially non-compliant cryogen ventilation. Over 17,228 superconducting magnetic resonance imaging devices may have cryogen venting systems that fail to meet FDA requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0642-2022·2022-02-16

    Natural Way Cheese Cheddar Curds recalled for improper milk storage

    Natural Way Cheese is recalling Cheddar Cheese Curds because milk used in production was stored in a holding tank for longer than the required 72-hour cleaning interval, creating potential for contamination.

    Product
    Natural Way Cheese Cheddar Cheese Curds, retail 12oz plastic bag UPC 8 10056 75023 7, 12 retail units per wholesale case, and sold in 10lbs wholesale plastic bag as well
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0569-2022·2022-02-16

    R82 by ETAC Push Brace for High-Low recalled due to cracking hazard

    The R82 by ETAC Push Brace for High-Low is being recalled because the chrome surface can crack during use, potentially cutting users. Approximately 396 units manufactured between August and October 2021 are affected.

    Product
    R82 by ETAC Push Brace for High-Low
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22E009000·2022-02-16

    Fuel Helmets Recalls SH-WS001 Motorcycle Helmets for Impact Protection Defect

    Fuel Helmets is recalling specific SH-WS001 motorcycle helmets that may not adequately protect the wearer in a crash. Owners will receive a credit to replace or reimburse the helmet.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0610-2022·2022-02-16

    GE Healthcare MRI Superconducting Magnets: Cryogen Ventilation System Defect

    GE Healthcare is recalling 17,228 MRI systems because the cryogen ventilation system may not meet venting requirements. The company is providing field corrections to ensure proper ventilation.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0638-2022·2022-02-16

    Natural Way Cheese Bacon Cheddar Cheese Curds recalled for improper storage

    Natural Way Cheese Bacon Cheddar Cheese Curds are being recalled in Michigan and Indiana because milk used in production was stored in a holding tank exceeding the required 72-hour cleaning interval.

    Product
    Natural Way Cheese Bacon Cheddar Cheese Curds, retail 12oz plastic bag UPC 8 10056 75175 3, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0637-2022·2022-02-16

    Natural Way Cheese 3 Pepper Cheese Curds recalled for improper milk storage

    Natural Way Cheese is recalling 3 Pepper Cheese Curds (12oz bags) distributed in Michigan and Indiana due to milk stored in a holding tank for more than 72 hours, exceeding required cleaning intervals.

    Product
    Natural Way Cheese 3 Pepper Cheese Curds, retail 12oz plastic bag UPC 8 10056 75020 6, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0591-2022·2022-02-16

    GE Healthcare MRI magnets recalled for cryogen ventilation defect

    GE Healthcare is recalling 17,228 MRI system magnets with potential cryogen ventilation defects. No injuries have been reported.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V088000·2022-02-16

    2022 Lincoln Aviator Fuel Filler Tube May Detach During Crash

    Ford is recalling certain 2022 Lincoln Aviator vehicles because the fuel filler tube may detach during a crash, creating a fuel leak and fire risk. Free repairs are available from Ford dealers.

    Product
    FORD — FORD, LINCOLN EXPLORER, AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22080·2022-02-16

    Esme Children's Sleepwear Garments Fail Flammability Standards

    Esme is recalling about 3,600 children's sleepwear garments because they fail federal flammability standards and pose a burn risk. Consumers should stop using them immediately and contact Esme for a free replacement or refund.

    Product
    Children's Sleepwear Garments
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2022·2022-02-16

    GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defects

    GE Healthcare is recalling MR superconducting magnets used in SIGNA Voyager MRI systems due to cryogen ventilation systems that may not meet venting requirements. The recall affects 17,228 devices.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0616-2022·2022-02-16

    GE Healthcare MR Superconducting Magnets Cryogen Ventilation System Defect

    GE Healthcare is recalling 17,228 superconducting magnetic resonance imaging systems due to potential cryogen ventilation system defects that may not meet safety venting requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V081000·2022-02-16

    Lamborghini Recalls Huracan Models Due to Missing Headlight Adjustment Caps

    Lamborghini is recalling 2015-2020 Huracan vehicles because missing caps on headlight adjustment screws can lead to improper alignment, reducing visibility and increasing crash risk.

    Product
    LAMBORGHINI — LAMBORGHINI HURACAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2022·2022-02-16

    Dologen 325 Caplet Recalled for CGMP Deviations

    ULTRAtab Laboratories, Inc. has voluntarily recalled Dologen 325 Caplet bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 917,304 tablets that were distributed to three distributors.

    Product
    Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0548-2022·2022-02-16

    Acetaminophen 325 mg Pamabrom Tablets Recalled Due to Manufacturing Violations

    ULTRAtab Laboratories voluntarily recalled approximately 6.4 million APAP 325 mg tablets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished products.

    Product
    APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0636-2022·2022-02-16

    Microbiologics Recalls KWIK-STIK Microorganism Reference Material Due to Organism Mislabeling

    Microbiologics Inc is recalling KWIK-STIK microorganism reference kits labeled as Actinomyces odontolyticus but containing Eggerthella lenta. The mislabeling could cause incorrect organism identification in laboratory testing.

    Product
    KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0528-2022·2022-02-16

    Drug Recall: Acetaminophen Phenylephrine Tablets for CGMP Deviations

    ULTRAtab Laboratories is recalling Coated APAP 325 mg Phenylephrine HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects bulk product distributed to three distributors.

    Product
    Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0541-2022·2022-02-16

    Trial Antacid Tablet bulk containers recalled for CGMP deviations

    ULTRAtab Laboratories is recalling Trial Antacid Tablet bulk containers (Calcium Carbonate 420 mg) due to CGMP deviations. The product was distributed to three distributors who may have distributed finished product.

    Product
    Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0567-2022·2022-02-16

    Dunnage Case Shipped Instead of THERAKOS CELLEX Photopheresis Kits

    A dunnage case containing sterilization packaging was shipped in place of THERAKOS CELLEX Photopheresis Procedural Kits. The material is not intended for customer use and should not be used.

    Product
    THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0723-2022·2022-02-16

    Caffeine dietary supplement recalled due to manufacturing practice deviations

    ULTRAtab Laboratories' caffeine and vitamin B-complex supplement is being recalled due to cGMP (Good Manufacturing Practice) deviations. The voluntary recall affects approximately 1,904,760 tablets distributed to wholesalers.

    Product
    Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0729-2022·2022-02-16

    Melatonin supplement MidNite Tablet recalled for manufacturing deviations

    ULTRAtab Laboratories voluntarily recalled MidNite Tablet melatonin supplements due to manufacturing practice deviations. The recall encompasses 42,352,387 tablets distributed in bulk to two distributors in New York and Florida.

    Product
    MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0722-2022·2022-02-16

    Electrolyte Tablets Recalled by ULTRAtab Laboratories Due to Manufacturing Deviations

    ULTRAtab Laboratories has recalled approximately 26.6 million electrolyte tablets due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.

    Product
    Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0555-2022·2022-02-16

    Cystex Tablet Recall Due to CGMP Manufacturing Deviations

    ULTRAtab Laboratories is voluntarily recalling Cystex Tablets (Sodium Salicylate 162.5 mg, Methenamine 162 mg) in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The bulk product was distributed to 3 distributors.

    Product
    Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0553-2022·2022-02-16

    Drug Recall: Coated Back Relief Tablet CGMP Deviations

    ULTRAtab Laboratories, Inc. voluntarily recalls approximately 25.8 million tablets of Coated Back Relief Tablet due to current good manufacturing practice (CGMP) deviations detected during production.

    Product
    Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0530-2022·2022-02-16

    Drug Recall: APAP 500 mg Phenyl HCl Tablets for CGMP Deviations

    ULTRAtab Laboratories is recalling approximately 14.3 million tablets of APAP 500 mg Phenyl HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

    Product
    APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0725-2022·2022-02-16

    Caffeine vitamin supplement tablets recalled for manufacturing deviations

    ULTRAtab Laboratories is voluntarily recalling 1,393,353 caffeine supplement tablets due to manufacturing practice deviations.

    Product
    Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0531-2022·2022-02-16

    Acetaminophen 325 mg bulk tablets recalled for manufacturing deviations

    ULTRAtab Laboratories is recalling approximately 3.7 million acetaminophen 325 mg tablets due to Good Manufacturing Practice (CGMP) deviations discovered in the manufacturing process.

    Product
    APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0582-2022·2022-02-16

    Medical device reference standard contaminated with bacterial species

    Microbiologics recalls KWIK-STIK Streptococcus pneumoniae reference standards due to potential contamination with Staphylococcus epidermidis, E. coli, and Staphylococcus warneri affecting 271 units worldwide.

    Product
    KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0535-2022·2022-02-16

    Extra-Strength Unaspirin Caplet Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Extra-Strength Unaspirin caplets (Acetaminophen 500 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 6.2 million tablets distributed to three distributors.

    Product
    Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0640-2022·2022-02-16

    Natural Way Cheese Dill Cheese Curds Recalled for Improper Milk Storage

    Natural Way Cheese is recalling Dill Cheese Curds because milk was stored in a holding tank longer than the required 72-hour cleaning interval. The improper storage creates a potential food safety risk.

    Product
    Natural Way Cheese Dill Cheese Curds, retail 12oz plastic bag UPC 8 10056 75019 0, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0540-2022·2022-02-16

    Cherry Antacid Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Cherry Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this as a Class II recall.

    Product
    Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0526-2022·2022-02-16

    Drug recall: Kramer Novis Tusicof caplet CGMP deviations

    ULTRAtab Laboratories is recalling Kramer Novis Tusicof caplets due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 639,729 tablets distributed to three wholesalers.

    Product
    Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0534-2022·2022-02-16

    Drug Recall: Coated APAP 500 mg Caplets for CGMP Deviations

    ULTRAtab Laboratories, Inc. is recalling approximately 2 million Coated APAP 500 mg caplets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished product.

    Product
    Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0537-2022·2022-02-16

    APAP 500 mg Acetaminophen Recalled Due to CGMP Deviations

    ULTRAtab Laboratories is recalling APAP 500 mg SRC Coated tablets in bulk due to manufacturing process deviations. The company voluntarily initiated the Class II recall on January 26, 2022.

    Product
    APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0728-2022·2022-02-16

    Melatonin ER supplement recalled for manufacturing practice deviations

    ULTRAtab Laboratories voluntarily recalled Melatonin ER 5 mg caplets due to manufacturing deviations. The bulk product distributed to wholesalers in New York and Florida may have been repackaged and resold.

    Product
    Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0529-2022·2022-02-16

    APAP 325 mg/Phenylephrine HCl 5 mg Tablets Bulk Container Recall

    ULTRAtab Laboratories is recalling approximately 451,123 APAP 325 mg/Phenylephrine HCl 5 mg tablets in bulk containers due to CGMP deviations. The product was distributed to three distributors for further distribution as finished goods.

    Product
    APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0544-2022·2022-02-16

    Ephedrine 25 Guaifenesin 200 Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Ephedrine 25 Guaifenesin 200 bulk tablets due to manufacturing practice deviations. The voluntary recall affects about 7.3 million tablets distributed to three drug wholesalers.

    Product
    Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0551-2022·2022-02-16

    Back Relief II Drug Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Back Relief II tablets due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated the voluntary recall of approximately 1.48 million tablets.

    Product
    Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0554-2022·2022-02-16

    DBI Magnums Caffeine Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories, Inc. is voluntarily recalling DBI Magnums Tablet (Caffeine 200 mg) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 8.7 million tablets distributed to three distributors.

    Product
    DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0550-2022·2022-02-16

    Pain Aid PMF Caplet Drug Recall for CGMP Deviations

    ULTRAtab Laboratories is recalling Pain Aid PMF Caplets due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated the voluntary recall of approximately 1.6 million tablets in bulk form distributed to three distributors.

    Product
    Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0538-2022·2022-02-16

    HPC Tablet Drug Recalled Due to CGMP Manufacturing Deviations

    ULTRAtab Laboratories is recalling HPC Tablet (a combination of acetaminophen, aspirin, caffeine, and salicylamide) due to manufacturing deviations. The recall affects approximately 50 million tablets distributed in bulk to three distributors.

    Product
    HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0637-2022·2022-02-16

    LYSO Disk microorganism culture device mislabeled with incorrect strain

    Microbiologics' LYSO Disk culture disks labeled as containing Actinomyces odontolyticus have been found to actually contain Eggerthella lenta. The mislabeling affects products distributed to Canada and Germany.

    Product
    LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk"…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateCPSC·22084·2022-02-16

    Scarves Recalled for Flammability Standard Violation and Burn Risk

    In-Things Corporation is recalling about 200 "Sparkle Sheer Social Wrap" scarves sold online because they fail to meet federal flammability standards for textiles, posing a burn injury risk.

    Product
    Scarves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0546-2022·2022-02-16

    Drug Recall: Phenylephrine HCl 5mg Tablets Bulk Container

    ULTRAtab Laboratories is recalling approximately 7.9 million Coated Phenylephrine HCl 5mg tablets in bulk containers due to manufacturing process deviations that may affect product quality and safety.

    Product
    Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0547-2022·2022-02-16

    Migrenol Caplet Drug Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 990,197 tablets distributed to three distributors.

    Product
    Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0542-2022·2022-02-16

    Spearmint Antacid Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Spearmint Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to manufacturing process deviations. The recall affects approximately 1.5 million tablets distributed to three distributors.

    Product
    Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
    Category
    Drug
    Distribution
    0 states

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