Archive
533 recalls were announced in June 2013.
Of the 533 recalls this month scored against our rubric, 5% are Critical, 33% are Severe.
Which agencies issued them
TG United, Inc. is recalling Poly-Vent DM Tablets because the products are underdosed or have an incorrect dosage regime.
Pentec Health is recalling Proplete 80+ KG renal nutritional prescriptions because sterility could not be assured for the compounded sterile products.
The Compounding Shop is recalling Lipoic Acid 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
TG United, Inc. is recalling 40,149 bottles of Trigofen DM Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling 355 bottles of AMBI antihistamine and nasal decongestant syrup due to CGMP deviations resulting in underdosed products.
Hospira Inc. is recalling 44,748 bags of Dobutamine in Dextrose Injection because a confirmed leak in the primary container raises concerns about sterility.
TG United, Inc. is recalling 2,388 bottles of Z-Dex Syrup because the product is underdosed or has an incorrect dosage regime.
The Compounding Shop is recalling Avastin injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
TG United, Inc. is recalling Cardec DM Drops because the products are underdosed or have an incorrect dosage regime.
Pentec Health is recalling Baxter LL bag 2% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Pentec Health is recalling Baxter LL bag 1% Amino Acids w/KCL because sterility could not be assured for these compounded sterile renal nutritional prescriptions.
TG United, Inc. is recalling specific lots of AMBI 40PSE/400GFN/20DM cough suppressant and expectorant bottles due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
TG United, Inc. is recalling Poly-Vent IR and DM tablets because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling 22,721 bottles of Brompheniramine/Pseudoephedrine DM liquid because the product is underdosed or has an incorrect dosage regime.
The Compounding Shop is recalling Mitomycin 0.3 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
Hospira Inc. is recalling 95,700 vials of Diazepam Injection due to a loose crimp on the fliptop vial, which compromises sterility assurance.
The Compounding Shop is recalling Dexamethasone 10 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The Compounding Shop is recalling Glutathione 200 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
TG United, Inc. is recalling ZoDen DM Drops because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling Z-Dex Pediatric Drops because the products are underdosed or have an incorrect dosage regime.
The Compounding Shop is recalling Morphine Sulfate 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Pentec Health is recalling Proplete 90+ KG dialysate solution because sterility could not be assured. The product was distributed to dialysis centers and directly to patients.
TG United, Inc. is recalling Cardec Drops nasal decongestant because the product is underdosed or has an incorrect dosage regime.
Intuitive Surgical is recalling approximately 132,441 EndoWrist Monopolar Curved Scissors instruments worldwide. The recall addresses potential cracks that may cause electrosurgical energy leaks and thermal injury to tissue.
The Compounding Shop is recalling Baclofen 1,000 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
The FDA is recalling 23,050 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially causing components to enter the patient's cavity.
Pentec Health is recalling 9 bags of Proplete 40 intradialytic parenteral nutrition due to a lack of assurance of sterility.
TG United, Inc. is recalling 386 bottles of TG 40PSE/400GFN tablets because they are underdosed or have an incorrect dosage regime.
Pentec Health is recalling Baxter LL bag 1.5% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
The Compounding Shop is recalling MIC Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
Pentec Health is recalling Baxter LL bag 1% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
The FDA is recalling 5,364 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially allowing components to enter the patient's cavity.
Pentec Health is recalling 59 bags of Proplete 60-69 KG intradialytic parenteral nutrition due to a lack of assurance of sterility.
The Compounding Shop is recalling Testosterone Cypionate 200 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
Pentec Health is recalling Baxter Ultrabag 1.5% Amino Acids because sterility could not be assured for compounded sterile renal nutritional prescriptions.
TG United, Inc. is recalling ED A-Hist Tablets because they are underdosed or have an incorrect dosage regime.
The Compounding Shop is recalling 43 vials of Sodium EDTA Injectable because FDA inspections raised concerns about quality control and sterility assurance.
TG United, Inc. is recalling ZoDen PD nasal spray bottles because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling Maxifed DM tablets because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling specific lots of Trigofen Drops because the products are underdosed or have an incorrect dosage regime.
Pentec Health is recalling Proplete 52 intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
TG United, Inc. is recalling Ryddex G Tablets because they are underdosed or have an incorrect dosage regime. The recall affects 2,957 bottles distributed in five states.
The Compounding Shop is recalling compounded Ascorbic Acid 500 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter the patient's cavity.
TG United, Inc. is recalling 348 bottles of AMBI cold and flu syrup due to CGMP deviations resulting in underdosed products.
Kreg Medical Inc. is recalling 59 E-Z Wider Bariatric Chair Beds because the bed frame collapsed during patient use, leaving the patient in a forward tilt position.
TG United, Inc. is recalling 1,623 bottles of Maxifed-G tablets because the products are underdosed or have an incorrect dosage regime.
FDA Class II recall of 126,925 Versaport trocars because seals may disengage, risking component entry into the patient's cavity.
Medtronic is recalling NIM TriVantage EMG Endotracheal Tubes because the cuff may leak during surgery, requiring re-inflation or replacement to maintain patient ventilation.
Symbios Medical Products is voluntarily recalling GoPump infusion pumps and kits due to reports of excessively high flow rates.
The Compounding Shop is recalling MIC + B12 injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
TG United, Inc. is recalling CPM / PSE DM Drops because the products are underdosed or have an incorrect dosage regime.
Stryker is recalling T4 Toga pullovers because accelerated aging tests suggest the sterile barrier may fail within the second or third year of shelf life.
Salsa Cycles is recalling specific Vaya and La Cruz bicycle forks because they can bend above the disc brake mount, posing a fall hazard to riders.
Zimmer Surgical Inc is recalling 13 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently during surgery.
Chemi-Source Inc. is recalling MRM All Natural Whey Dutch Chocolate products because the whey ingredient was not listed as milk, a major allergen.
HP Hood LLC is recalling 1% Low Fat Cottage Cheese under multiple brands due to the possible presence of metal fragments.
HP Hood LLC is recalling 4% cottage cheese under multiple brands due to the possible presence of metal fragments. The product was distributed in 21 states.
Chemi-Source Inc is recalling Isolate Whey Protein Chocolate Malt because the whey ingredient was not listed as milk, a major allergen.
Stryker is recalling T5 zipper Toga surgical drapes because accelerated aging tests indicate a potential breach in the sterile barrier within the second and third year of shelf life.
American Optisurgical is recalling 194 TX1 Tissue Removal System Consoles due to a defect in the overheating protection circuit that may cause the device to lose power during use.
Alcon is removing 8,455 Constellation Pneumatic Handpieces from the market because forceps or scissors tips may dislodge if not attached according to instructions.
Cordis is recalling 784 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.
Hill-Rom is recalling 412 SlingBar Wide 670 patient lifts because a retrospective review found a potential for impalement if a person falls onto the hooks.
Cordis Corporation is recalling 23 units of FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.
Stryker is recalling T4 Toga Zipper sterile surgical gowns due to potential sterile barrier breaches in packaging identified during accelerated aging tests.
Zimmer Surgical Inc is recalling 84 units of the Zimmer Air Dermatome because broken planetary gear teeth may cause the device to fail during surgery.
Gyrus Acmi is recalling disposable myringotomy knives because they may lack sterility assurance. The affected units were distributed in the US, Canada, and the UK.
Stryker is recalling 1,980 units of T5 Pullover Togas due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
Chemi-Source Inc. is recalling It Works Ultimate Profit Vanilla whey protein because the milk allergen was not listed on the label.
Philips Medical Systems is recalling 505 BrightView SPECT gamma cameras worldwide after a report of unexpected detector motion caused by a mechanical assembly failure.
Chemi-Source Inc is recalling Sprouts Farmers Market Whey Protein Chocolate because the whey ingredient was not listed as milk, a major allergen.
Cordis is recalling 1,357 FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.
Stryker is recalling T4 Toga sterile surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
I-Flow LLC is voluntarily removing 75 units of the ON-Q Pain Relief System T-Block Needle/Catheter Kit because they may have potentially malfunctioned.
Chemi-Source Inc is recalling Low Carb Protein - French Vanilla because the whey and casein ingredients are not listed as milk, a major allergen.
Chemi-Source Inc. is recalling Isolate Whey Protein French Vanilla because the milk allergen was not listed on the label.
GE Healthcare is recalling 800 reusable CO2 absorbent canisters used with anesthesia systems because they may not seal properly.
LL Bakery is recalling specific bread and Danish products because the labels fail to declare milk as an allergen in the whey powder.
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured with flow control components assembled prior to July 2012 due to reports of excessively high flow rates.
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.
McNeilus is recalling 978 Bridgemaster V Concrete Mixers because fender brackets may crack and detach, creating a road hazard.
Chemi-Source Inc is recalling All Natural Whey protein products because the milk ingredient was not listed on the label, posing a risk to consumers with milk allergies.
Whole Foods Market is recalling Curried Vegan Chick N Salad due to an undeclared soy allergen. The product was sold in six northeastern states.
LL Bakery is recalling specific breads and pastries because the labels fail to declare milk as an allergen.
Chemi-Source Inc. is recalling Delicious Whole-istic Whey Protein Duch Chocolate because the milk allergen was not listed on the label.
Chemi-Source Inc. is recalling Massive Muscle Gainer weight gainer because the milk ingredient was not listed as an allergen, posing a risk to consumers with milk allergies.
TG United, Inc. is recalling 886 bottles of AMBI 40PSE/400GFN tablets because the products are underdosed or have an incorrect dosage regime.
Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging during the second and third years of shelf life.
Hill-Rom is recalling 726 SlingBar Standard units because a retrospective review found a potential for impalement if a person falls onto the hooks.
Cordis Corporation is recalling 310 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.
Stryker is recalling T5 Zipper Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
SpineFrontier, Inc. is recalling 10 Straight Impactor - Dorado IBC devices because the impactor plate on the handle broke off during use.
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured with flow control components assembled prior to July 2012 due to reports of excessively high flow rates.
Chemi-Source Inc is recalling Fruit-N-Whey protein powder because the whey ingredient was not listed as a milk allergen, posing a risk to consumers with milk allergies.
Chemi-Source Inc. is recalling Metabolic Whey protein products because milk and soy allergens were not properly labeled. Consumers with allergies to these ingredients should stop using the product.
LL Bakery is recalling White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because the labels fail to declare milk as an allergen.
Chemi-Source Inc is recalling All Natural Whey protein products because the milk allergen was not listed on the label.
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