The Recall Desk

Archive

June 2013 recalls

533 recalls were announced in June 2013.

What the numbers show

Critical
24
Severe
176
High
192
Moderate
108
Low
33

Of the 533 recalls this month scored against our rubric, 5% are Critical, 33% are Severe.

301–400 of 533

  • HighFDA (Food)·F-1484-2013·2013-06-12

    It Works Ultimate Profit Chocolate Protein Powder Recalled for Milk Allergen Mislabeling

    Chemi-Source Inc is recalling It Works Ultimate Profit Chocolate protein powder because the whey ingredient was not listed as a milk allergen.

    Product
    It Works Ultimate Profit Chocolate¿1.6 LBS: Whey Protein Concentrate/ Isolate, Soy Protein Extract, Soy Hull Fiber; Soy Protein Isolate; Contains: Dairy, Cocoa
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1487-2013·2013-06-12

    Chemi-Source Casein Powder Recalled for Unlabeled Milk Allergen

    Chemi-Source Inc. is recalling 1,320 units of 100% Micellar Casein powder because the milk ingredient was not listed as an allergen.

    Product
    Casein - 100% Micellar Casein - Cookies & Cream¿2.02 LBS: Soy Lecithin,Casein/Caseinate,Wheat UPC 6-09492 72242-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1502-2013·2013-06-12

    Sprouts Farmers Market Whey Protein Strawberry Recalled for Undeclared Milk Allergen

    Sprouts Farmers Market Whey Protein Strawberry is being recalled because the whey ingredient is not listed as milk, an allergen. Consumers with milk allergies are at risk of serious reactions.

    Product
    Sprouts Farmers Market Whey Protein Strawberry: 1 lbs, 2 lbs : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68122-6 (1 lbs) UPC 6-46670 68128-8 (2 lbs):
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1500-2013·2013-06-12

    Sprouts Farmers Market Whey Protein Vanilla Recalled for Undeclared Milk Allergen

    Sprouts Farmers Market Whey Protein Vanilla is being recalled because the whey ingredient is not listed as milk, a major allergen. Consumers with milk allergies are at risk of serious allergic reactions.

    Product
    Sprouts Farmers Market Whey Protein Vanilla: 1 lbs, 2 lbs : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68118-9 (1 lbs) UPC 6-46670 68124-0 (2 lbs)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1481-2013·2013-06-12

    Chemi-Source Low Carb Protein Recalled for Undeclared Milk Allergen

    Chemi-Source Inc is recalling Low Carb Protein products because the whey ingredient is not listed as milk, a major allergen.

    Product
    Low Carb Protein -¿Strawberry/Banana¿1.78 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate,Soy Lecithin, Red Beet Powder UPC 6-09492 72018-4
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1471-2013·2013-06-12

    Hood Cottage Cheese with Chive Recalled for Possible Metal Fragments

    HP Hood LLC is recalling specific lots of Cottage Cheese with Chive due to the possible presence of metal fragments.

    Product
    Cottage Cheese with Chive distributed under the following labels and sizes: (a) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 16 OZ. (453g), UPC 044100102264, HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT,
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-1486-2013·2013-06-12

    Chemi-Source Micellar Casein Recalled for Unlabeled Milk Allergen

    Chemi-Source Inc. is recalling 2,932 units of 100% Micellar Casein (Rich Chocolate) because the milk ingredient was not listed as an allergen.

    Product
    Casein - 100% Micellar Casein - Rich Chocolate¿2.02 LBS: Soy Lecithin,Casein/Caseinate, Cocoa UPC 6-09492 72240-9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1492-2013·2013-06-12

    Chemi-Source Low Carb Protein Recalled for Undeclared Milk Allergen

    Chemi-Source Inc. is recalling Low Carb Protein Creamy Chocolate because the milk ingredient is not listed on the label, posing a risk to consumers with milk allergies.

    Product
    Low Carb Protein¿ -¿ Creamy Chocolate¿1.78 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 72017-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1489-2013·2013-06-12

    Massive Muscle Gainer Recalled for Undeclared Milk Allergen

    Chemi-Source Inc is recalling Massive Muscle Gainer weight gainer because the whey and casein ingredients are not listed as milk, a major allergen.

    Product
    Massive Muscle Gainer- Weight Gainer¿ French Vanilla¿10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate UPC 6-09492 73003-9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1488-2013·2013-06-12

    Micellar Casein Powder Recalled for Undeclared Milk Allergen

    Chemi-Source Inc. is recalling 1,182 units of Micellar Casein powder because the milk ingredient was not listed as an allergen.

    Product
    Casein - 100% Micellar Casein - Vanilla Ice Cream¿2.04 LBS: Soy Lecithin,Casein/Caseinate UPC 6-09492 72241-6
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1491-2013·2013-06-12

    All Natural Gainer Protein Powder Recalled for Unlabeled Milk Allergen

    Chemi-Source Inc. is recalling All Natural Gainer protein powder because the milk ingredient was not listed on the label, posing a risk to consumers with milk allergies.

    Product
    All Natural Gainer- Rich Vanilla¿3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate UPC 6-09492 73003-9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1493-2013·2013-06-12

    All Natural Gainer Chocolate Protein Powder Recalled for Undeclared Milk Allergen

    Chemi-Source Inc is recalling All Natural Gainer Chocolate protein powder because the milk ingredient was not listed on the label.

    Product
    All Natural Gainer - Chocolate¿3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 73004-6
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1497-2013·2013-06-12

    Flax-N-Whey Protein Recall for Undeclared Milk Allergen

    Chemi-Source Inc. is recalling Flax-N-Whey products because the whey ingredient contains milk, a major allergen, that is not listed on the label.

    Product
    Flax-N-Whey and Flax-N-Whey Vanilla Nut 1.99 lbs: Whey Protein/Isolate Contains: Soy, Dairy, Flaxseed UPC 6-09492 72064-1
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1483-2013·2013-06-12

    Chemi-Source Metabolic Whey Recalled for Undeclared Milk and Soy Allergens

    Chemi-Source Inc. is recalling Metabolic Whey protein powder because the packaging fails to list milk and soy as ingredients. Consumers with allergies to these substances are at risk of serious allergic reactions.

    Product
    UPC6-09492 72050-4, 72053-5 , Metabolic Whey - Rich Chocolate¿5 LBS, 10 LBS : Whey Protein Concentrate/ Isolate, Cocoa
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1482-2013·2013-06-12

    Metabolic Whey Protein Recalled for Unlabeled Milk and Soy Allergens

    Chemi-Source Inc is recalling Metabolic Whey protein products because milk and soy allergens were not listed on the labels.

    Product
    Metabolic Whey - Straw/Banana¿5 LBS & 10 LBS: Whey Protein Concentrate/ Isolate, UPC 6-09492 72052-8, 72055-9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2013·2013-06-12

    Hill-Rom Recalls SlingBar 350 Patient Lifting Devices Due to Impalement Risk

    Hill-Rom is recalling 3,556 SlingBar 350 patient lifting devices because a retrospective review found four units may present a potential for impalement if a person falls onto the hooks.

    Product
    SlingBar 350. Designed to meet the needs for lifting humans.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2013·2013-06-12

    Symbios Recalls GoPump and GoBlock Kits Due to Flow Control Defects

    Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to flow control components that may cause excessively high flow rates.

    Product
    Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2013·2013-06-12

    Stryker T4 Zipper Toga Recall for Potential Sterile Barrier Breach

    Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2013·2013-06-12

    Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues

    Symbios Medical Products is voluntarily recalling GoPump Rapid Recovery System kits because some units may deliver medication at excessively high flow rates.

    Product
    Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1505-2013·2013-06-12

    American Optisurgical Recalls ChloraPrep Applicators Due to Seal Defect

    American Optisurgical is recalling ChloraPrep Hi-Lite Orange 3mL Applicators because an incomplete seal on the packaging may have compromised sterility assurance.

    Product
    FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2013·2013-06-12

    Shimadzu Mobile X-ray Systems Recalled for Loose Internal Screws

    Shimadzu Medical Systems is recalling 200 Mobile DaRt Evolution X-ray systems due to a potential risk of internal screws becoming loose.

    Product
    Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2013·2013-06-12

    Cordis FLEXSTENT Stent System Recalled for Pouch Integrity Defects

    Cordis Corporation is recalling 250 units of FLEXSTENT stent systems because holes or tears can form in the protective pouches.

    Product
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2013·2013-06-12

    FDA Recalls Versaport Bladeless Optical Fixation Cannulas Due to Seal Disengagement

    The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter the patient's cavity.

    Product
    Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2013·2013-06-12

    I-Flow ON-Q Pain Relief System T-Block Needle/Catheter Tray Recall

    I-Flow LLC is voluntarily removing 450 units of the ON-Q Pain Relief System T-Block Needle/Catheter Tray because the devices may have malfunctioned.

    Product
    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2013·2013-06-12

    Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Control Defect

    Symbios Medical Products is voluntarily recalling GoPump Rapid Recovery System kits and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.

    Product
    Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; GoPump kit 510112-BP, 2.5" fenestrated catheter & BIOPATCH Go Pump Kit 5101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1488-2013·2013-06-12

    Berchtold Recalls Hand Controls for Operon Surgical Tables

    Berchtold Corp. is recalling 3,763 hand controls for Operon surgical tables due to reports of unintended movements.

    Product
    Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2013·2013-06-12

    Hill-Rom Recalls SlingBar 360 Patient Lifting Devices Due to Impalement Risk

    Hill-Rom is recalling 16 SlingBar 360 patient lifting devices because a retrospective review found a potential for impalement if a person falls onto the hooks.

    Product
    SlingBar 360. Designed to meet the needs for lifting humans.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1487-2013·2013-06-12

    AGFA DX-D 100 X-Ray System Recalled for Unintended Movement

    AGFA Corp. is recalling 104 DX-D 100 digital radiography systems because they may experience intermittent, unintended, and illogical movement during use.

    Product
    AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1489-2013·2013-06-12

    Stryker T4 Pullover Toga Recalled for Potential Sterile Barrier Breach

    Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1468-2013·2013-06-12

    DiGiorno Bianca Pizza Recalled for Potential Plastic Contamination

    Nestle USA is recalling specific DiGiorno Bianca pizzas due to potential clear plastic fragments. Consumers should check production codes and discard affected items.

    Product
    DiGiorno pizzeria, bianca/white pizza , Net Wt.18.0 OZ (510 g), UPC 71921-91484
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1463-2013·2013-06-12

    Intuitive Surgical Recalls da Vinci 5 mm Instrument Cannulae for Inspection Changes

    Intuitive Surgical is voluntarily modifying the inspection process for da Vinci 5 mm Instrument Cannulae used in surgical systems.

    Product
    da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1446-2013·2013-06-12

    Leica Microsystems Recalls LPC Fine Mesh Cassettes for Closure Failure

    Leica Microsystems is recalling LPC Fine Mesh Cassettes because they failed to stay closed during processing operations. The recall affects 20,160 units distributed in the US and New Zealand.

    Product
    LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1451-2013·2013-06-12

    Maytex Comfort Ear-Loop Face Masks Recalled for Performance Failures

    Maytex Corp is recalling 43,915 cases of Comfort brand Ear-Loop Face Masks because lab testing showed they do not meet stated differential pressure standards and cannot be guaranteed as fluid resistant.

    Product
    Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1486-2013·2013-06-12

    Coloplast Recalls Digitex Sutures Due to Incorrect Expiration Date Labeling

    Coloplast is recalling three lots of Digitex Absorbable Polydiaxanone Sutures because they are mislabeled with a three-year expiration date.

    Product
    Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1492-2013·2013-06-12

    Stryker T4 Toga Surgical Gowns Recalled for Potential Sterile Barrier Breach

    Stryker is recalling 3,000 units of T4 Toga surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-579-2013·2013-06-12

    Petnet Solution Recalls Fludeoxyglucose F 18 Injection Due to cGMP Deviation

    Petnet Solution Inc. voluntarily recalled 28 doses of Fludeoxyglucose F 18 Injection in California due to a cGMP deviation.

    Product
    Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1466-2013·2013-06-12

    Arizona Unsweetened Brewed Tea Recalled for Undeclared Splenda Ingredient

    Arizona Beverages USA LLC is recalling 10,286 cases of 1-gallon Arizona Southern Style Unsweetened Brewed Tea due to an undeclared Splenda ingredient.

    Product
    ORIGINAL BRAND Arizona SOUTHERN STYLE UNSWEETENED Brewed Tea, Net Wt. 128 FL.OZ (1 GAL.). Product is packaged in a cardboard case, each case contains four 1 Gallon plastic containers. UPC Code: 6 1300871981 4.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1512-2013·2013-06-12

    Siemens ADVIA Centaur iPTH Assay Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.

    Product
    ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-506-2013·2013-06-12

    TG United Recalls Underdosed AMBI Cough Syrup Bottles

    TG United, Inc. is recalling 348 bottles of AMBI cough syrup due to CGMP deviations resulting in underdosed products.

    Product
    AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-539-2013·2013-06-12

    TG United Recalls TL-Hist PD Drops Due to Underdosing

    TG United, Inc. is recalling 13,031 bottles of TL-Hist PD Drops because the product is underdosed or has an incorrect dosage regime.

    Product
    TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1440-2013·2013-06-12

    Zeiss OPMI Pentero C Surgical Microscope Ceiling Mount Recall

    Carl Zeiss Meditec is recalling six OPMI Pentero C surgical microscopes because broken screws were found in the ceiling mounts during routine inspections.

    Product
    Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-547-2013·2013-06-12

    Physicians Total Care Recalls Metronidazole Tablets for Weight Specification Failures

    Physicians Total Care is recalling Metronidazole Tablets, 500 mg, because some tablets may not conform to weight specifications. The recall covers 25,230 tablets distributed nationwide.

    Product
    Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bott
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1498-2013·2013-06-12

    Stryker Instruments Toga Sterile Barrier Recall

    Stryker is recalling T4 XXL Toga products due to potential sterile barrier breaches in packaging identified during accelerated aging tests.

    Product
    Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1517-2013·2013-06-12

    Invatec Diver C.E. Aspiration Catheters Recalled for Labeling Issues

    Invatec Llc is recalling 177 Diver C.E. aspiration catheters because the labeled indications for use were not included in the existing regulatory clearance.

    Product
    lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1513-2013·2013-06-12

    Siemens ADVIA Centaur iPTH Assay Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.

    Product
    ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1503-2013·2013-06-12

    Stryker T4 Toga Recall Due to Potential Sterile Barrier Breach

    Stryker is recalling 2,000 units of T4 Toga surgical drapes due to potential sterile barrier breaches identified in accelerated aging tests.

    Product
    Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1465-2013·2013-06-12

    Biomet Recalls Active Articulation E1 Hip Bearing Implants Due to Labeling Errors

    Biomet is recalling 8 units of Active Articulation E1 hip bearing implants because outer and inner labels display incorrect or conflicting outer diameter sizes.

    Product
    Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1497-2013·2013-06-12

    Stryker T4 Toga Surgical Drapes Recalled for Sterile Barrier Concerns

    Stryker is recalling T4 Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-570-2013·2013-06-12

    Praziquantel Vials Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Praziquantel 56.8 mg vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Food)·F1467-2013·2013-06-12

    Nestle Recalls California Pizza Kitchen Crispy Thin Crust Pizzas Due to Plastic

    Nestle is recalling specific California Pizza Kitchen Crispy Thin Crust White pizzas because they may contain fragments of clear plastic.

    Product
    california Pizza Kitchen crispy thin crust, White, Crispy thin crust pizza topped with garlic creme fraiche sauce, spinach, garlic, mozzarella,cheeses, parmesan, asiago and romano cheeses. Net Wt.12.8 OZ (363 g), UPC 71921-98745
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-535-2013·2013-06-12

    TG United Recalls Mesehist DM Due to CGMP Deviations

    TG United, Inc. is recalling Mesehist DM cough and cold medicine because the product is underdosed or has an incorrect dosage regime.

    Product
    Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1464-2013·2013-06-12

    Intuitive Surgical Recalls da Vinci 5 mm Flared Instrument Cannulae

    Intuitive Surgical is voluntarily recalling da Vinci 5 mm Flared Instrument Cannulae to implement a modified inspection process.

    Product
    da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1477-2013·2013-06-12

    Smiling Hill Farm Butter Recalled for Elevated Bacteria Counts

    Smiling Hill Farm is recalling butter due to elevated standard plate counts and detectable coliform bacteria. The product was distributed in Maine, New Hampshire, and Connecticut.

    Product
    Smiling Hill Farm brand Butter, 1/2 lb, 5 lb; Unlabeled: 1/2 lb, 5 lb, 30-40 lb (variable in 5 gallon buckets) Product in plastic snap-lid containers.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-533-2013·2013-06-12

    TG United Recalls CPM PSE Drops Due to CGMP Deviations

    TG United, Inc. is recalling CPM / PSE Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-507-2013·2013-06-12

    TG United Recalls Underdosed AMBI Cough Suppressant and Expectorant

    TG United, Inc. is recalling 348 bottles of AMBI cough suppressant and expectorant due to CGMP deviations resulting in underdosed products.

    Product
    AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1515-2013·2013-06-12

    Siemens ADVIA Centaur iPTH Calibrator Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.

    Product
    ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-516-2013·2013-06-12

    TG United Recalls NoHist Tablets Due to Underdosing

    TG United, Inc. is recalling NoHist Tablets because they are underdosed or have an incorrect dosage regime.

    Product
    NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1490-2013·2013-06-12

    Stryker T4 Pullover Toga Recall Due to Sterile Barrier Concerns

    Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1494-2013·2013-06-12

    Stryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach

    Stryker is recalling T4 Toga pullovers because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-526-2013·2013-06-12

    TG United Recalls BroveX PSB Liquid Due to CGMP Deviations

    TG United, Inc. is recalling BroveX PSB Liquid antihistamine and decongestant products because they are underdosed or have an incorrect dosage regime.

    Product
    BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1484-2013·2013-06-12

    Zimmer Air Dermatome II Recalled Due to Broken Planetary Gear Teeth

    Zimmer Surgical Inc is recalling 126 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently.

    Product
    Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1500-2013·2013-06-12

    Stryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns

    Stryker is recalling 5,000 units of T4 Toga Zipper products due to potential sterile barrier breaches identified in accelerated aging tests.

    Product
    Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1514-2013·2013-06-12

    Siemens ADVIA Centaur iPTH Calibrator Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.

    Product
    ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-527-2013·2013-06-12

    TG United Recalls BroveX PSB DM Liquid Due to Dosage Issues

    TG United, Inc. is recalling BroveX PSB DM Liquid antihistamine and decongestant products because they are underdosed or have an incorrect dosage regime.

    Product
    BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
    Category
    Drug
    Distribution
    5 states
  • LowFDA (Food)·F-1504-2013·2013-06-12

    Golden Flower Dried Ginger Recalled for Agriculture Law Violations

    Prosperity Resources International is recalling Golden Flower Dried Ginger in New York State due to violations of the Agriculture and Markets Law.

    Product
    Golden Flower Dried Ginger Net Wt. 6 oz (170g). Packed By: S&Y Co., LTD. No 12 Yuenjiang Road, Gaoming City Guangdong, China. Distributed by: Prosperity Resources Int'l., Inc. USA. Product of China.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-573-2013·2013-06-12

    Novartis Lamisil AT Cream Recalled for Illegible Lot and Expiration Dates

    Novartis is recalling Lamisil AT Cream because the lot and expiration dates on the tubes may be illegible. The recall covers 12-gm and 30-gm tubes distributed nationwide, in Puerto Rico, and in Panama.

    Product
    Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC c
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-596-2013·2013-06-12

    Voltaren 1% Gel Recalled for Illegible Lot and Expiration Dates

    Physicians Total Care is recalling 76 tubes of Voltaren 1% Gel because the lot number and expiration date on the tubes may not be legible.

    Product
    Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1477-2013·2013-06-12

    Bion Enterprises IgG Conjugate Recalled for Incorrect Expiration Date Labeling

    Bion Enterprises Ltd is recalling 207 units of IgG Conjugate because the labeled expiration date is one year too long.

    Product
    Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-574-2013·2013-06-12

    Novartis Recalls Target Up & Up Athlete's Foot Cream for Labeling Issues

    Novartis is recalling Target Up & Up athlete's foot cream because the lot and expiration dates on the tubes may not be legible.

    Product
    Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1441-2013·2013-06-12

    Optovue iVue Software Recall Due to Inconsistent Color Display

    Optovue, Inc. is recalling iVue software versions 3.0 and 3.1 because color displays for Ganglion Cell Complex thickness are inconsistent across different report types.

    Product
    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1479-2013·2013-06-12

    Bion Enterprises IgG FITC Conjugate Recalled for Incorrect Expiration Date

    Bion Enterprises is recalling 504 units of IgG FITC Conjugate because the labeled expiration date is one year too long.

    Product
    Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-576-2013·2013-06-12

    Novartis Recalls Lamisil AT Cream Due to Illegible Labeling

    Novartis Consumer Health is recalling specific lots of Lamisil AT Cream because the lot and expiration dates on the tubes may be illegible.

    Product
    Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-575-2013·2013-06-12

    Novartis Lamisil AT Cream Recalled for Illegible Lot and Expiration Dates

    Novartis is recalling 219,600 tubes of Lamisil AT Cream because the lot and expiration dates may be illegible.

    Product
    Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 00
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-578-2013·2013-06-12

    Teva Recalls Disulfiram Tablets Due to Missing Cotton Coil

    Teva Pharmaceuticals is recalling 68,322 bottles of Disulfiram Tablets USP 250 mg because some packaged bottles are missing a cotton coil.

    Product
    Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-577-2013·2013-06-12

    Novartis Recalls Voltaren Gel Due to Illegible Lot and Expiration Dates

    Novartis Consumer Health is recalling Voltaren Gel because lot and expiration dates on the tubes may be illegible. The FDA classifies this as a Class III recall.

    Product
    Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1478-2013·2013-06-12

    Bion Enterprises IgM Conjugate Recalled for Incorrect Expiration Date Labeling

    Bion Enterprises is recalling 201 units of IgM Conjugate because the labeled expiration date is one year too long.

    Product
    Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13C002000·2013-06-11

    Combi Recalls Child Seats Due to Harness Webbing Failure

    Combi USA is recalling specific child seats because the harness webbing fails to meet minimum breaking strength requirements, increasing injury risk in crashes.

    Product
    CHILD SEAT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V242000·2013-06-10

    Spartan Motor Homes Recalled for Front Wheel Bearing Fire Risk

    Spartan is recalling 2012-2013 K2, K3, and MM motor homes because incorrect front wheel bearings may cause the vehicle to pull and potentially start a fire.

    Product
    SPARTAN — SPARTAN K2, K3, MM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E031000·2013-06-07

    Mitsubishi Recalls 2012 i-MiEV Replacement Lithium-Ion Batteries

    Mitsubishi is recalling replacement lithium-ion batteries for 2012 i-MiEV vehicles due to internal contamination that may cause reduced voltage or short-circuits.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13736·2013-06-07

    Adobe Recalls High-Powered Magnets Distributed in Promotional Materials Package

    Adobe is recalling high-powered magnets distributed in a promotional package due to the risk of serious internal injury if swallowed by children.

    Product
    High-Powered Magnets distributed with Adobe Connect™ "Effective Collaboration is Magnetic" Promotional Materials Package
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13E033000·2013-06-07

    Kuryakyn Recalls Motorcycle Backrests Due to Loose Pivot Screws

    Kuryakyn is recalling specific motorcycle backrests because pivot screws may loosen, causing the backrest to separate and potentially leading to loss of control.

    Product
    SEATS:MOTORCYCLE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13212·2013-06-06

    Country Life Recalls Target-Mins Iron Supplements Due to Packaging Defect

    Country Life LLC is recalling Target-Mins Iron Supplement Bottles because the packaging is not child-resistant, posing a risk of serious injury or death to young children.

    Product
    Target-Mins™ Iron Supplement Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13209·2013-06-06

    Gerber Recalls Bear Grylls Parang Machetes with Stitched Sheaths

    Gerber is recalling Bear Grylls Parang Machetes with stitched sheaths because the blade can cut through the stitching, posing a laceration hazard.

    Product
    Gerber® Bear Grylls Parang Machete with stitched sheaths
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13210·2013-06-06

    IKEA Recalls LYDA Jumbo Cups Due to Burn Hazard

    IKEA is recalling LYDA jumbo coffee and tea cups because they can break when hot liquid is poured into them, posing a burn hazard.

    Product
    LYDA jumbo cups
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13211·2013-06-06

    Philips Recalls Metal Halide Lamps Due to Fire and Laceration Hazards

    Philips is recalling about 8,100 metal halide lamps because internal wiring can arc, posing fire and laceration risks. Consumers should stop using them and contact Philips for a refund or replacement.

    Product
    Metal Halide Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1452-2013·2013-06-05

    Pecan Deluxe Candy Company Recalls Peanut Butter Base for Salmonella Risk

    Pecan Deluxe Candy Company is recalling Peanut Butter Base because it was manufactured using peanut butter previously recalled by Sunland, Inc. for salmonella.

    Product
    Peanut Butter Base, 30 lb Pail, Item Numbers 08-010-30, 08-310-30, and 08-810-30, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-1450-2013·2013-06-05

    Pecan Deluxe Peanut Butter Fudge Ribbon Recalled for Salmonella Risk

    Pecan Deluxe Candy Company is recalling Peanut Butter Fudge Ribbon because it was made with peanut butter previously recalled for salmonella.

    Product
    Peanut Butter Fudge Ribbon, 50 lb Pail, Item Number 07-094-50, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-1448-2013·2013-06-05

    Pecan Deluxe Candy Company Recalls Peanut Butter Ribbon for Salmonella Risk

    Pecan Deluxe Candy Company is recalling Peanut Butter Ribbon because it was manufactured using peanut butter recalled by Sunland, Inc. for salmonella.

    Product
    Peanut Butter Ribbon, 40 lb Pail, Item Numbers 07-012-40, 07-212-40, and 49-00100-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-1465-2013·2013-06-05

    Arthur Schuman Grated Grana Padano Cheese Recalled for Listeria

    Arthur Schuman Midwest LLC is recalling specific lots of grated Grana Padano cheese because testing found Listeria monocytogenes.

    Product
    GRATED 2/25 GRANA PADANO; Lot Code: 313701A01; Pack Size: 2/25#; Net Pounds: 50; PACK DATE: 05/18/13; ITEM#DGP03; arthur schuman inc, 40 new dutch lane fairfield nj 07004 U.S.A.; 937-227-0030 www.arthurschuman.com;
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1461-2013·2013-06-05

    Whole Foods Peanut Butter Cookies Recalled Due to Salmonella Risk

    The Sourdough: A European Bakery Inc. is recalling Whole Foods 3 oz Peanut Butter Cookies because they were made with peanut butter recalled for salmonella.

    Product
    Whole Foods 3 oz Peanut Butter Cookies sold under PLU 47963 from the retail store self-serve pastry case.
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1451-2013·2013-06-05

    Pecan Deluxe Candy Company Recalls Chunky Peanut Butter Ribbon

    Pecan Deluxe Candy Company is recalling Chunky Peanut Butter Ribbon because it was manufactured using peanut butter recalled by Sunland, Inc. for salmonella.

    Product
    Chunky Peanut Butter Ribbon, 40 lb Pail, Item Number 07-712-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-1449-2013·2013-06-05

    Pecan Deluxe Peanut Butter Crunch Recalled for Salmonella Risk

    Pecan Deluxe Candy Company is recalling Peanut Butter Crunch because it was made with peanut butter previously recalled for salmonella.

    Product
    Peanut Butter Crunch, 45 lb Case, Item Number 01-326-45, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-1462-2013·2013-06-05

    Whole Foods Peanut Butter Chocolate Chunk Cookies Recalled for Salmonella Risk

    The Sourdough: A European Bakery Inc. is recalling Whole Foods peanut butter chocolate chunk cookies because they were made with peanut butter recalled for salmonella.

    Product
    Whole Foods 3 oz Peanut Butter Chocolate Chunk Cookies sold under PLU 47963 from the retail store self-serve pastry case.
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1460-2013·2013-06-05

    Whole Foods Mini Peanut Butter Cookies Recalled for Salmonella Risk

    The Sourdough: A European Bakery Inc. is recalling Whole Foods Mini Peanut Butter Cookies because they were made with peanut butter recalled for salmonella.

    Product
    Whole Foods Mini Peanut Butter Cookies 12 pack sold in small, plain brown bags featuring a cellophane window on the front with an oval Whole Foods Market sticker that reads "mini peanut butter cookies - OLD-FASHIONED TREATS FROM WHOLE FOOD MARKET-" PLU 22096100000
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-457-2013·2013-06-05

    Nora Apothecary Recalls PGE-1 Penile Injections Due to Sterility Concerns

    Nora Apothecary is recalling PGE-1 Penile Injections because FDA inspections raised concerns about quality control and the assurance of sterility.

    Product
    PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-477-2013·2013-06-05

    FDA Recalls HCG Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling HCG Inj 1200un/ml MDV products due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide

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