Archive
533 recalls were announced in June 2013.
Of the 533 recalls this month scored against our rubric, 5% are Critical, 37% are Severe.
Which agencies issued them
The Compounding Shop is recalling Dexpanthenol 200 mg/mL Injectable vials because FDA inspection findings raised concerns about quality control and sterility assurance.
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.
Hospira Inc. is recalling 95,700 vials of Diazepam Injection due to a loose crimp on the fliptop vial, which compromises sterility assurance.
TG United, Inc. is recalling 355 bottles of AMBI antihistamine and nasal decongestant syrup due to CGMP deviations resulting in underdosed products.
The Compounding Shop is recalling Baclofen/Bupivacaine injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
TG United, Inc. is recalling 348 bottles of AMBI 25CPD/200GFN antitussive and expectorant due to CGMP deviations involving incorrect dosage.
Pentec Health is recalling Fresenius 1% Amino Acid bags because sterility could not be assured for compounded renal nutritional prescriptions.
TG United, Inc. is recalling ZoDen DM Drops 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.
TG United, Inc. is recalling Poly Hist Forte nasal decongestant tablets because they are underdosed or have an incorrect dosage regime.
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.
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 Ryddex G Tablets because they are underdosed or have an incorrect dosage regime. The recall affects 2,957 bottles distributed in five states.
TG United, Inc. is recalling Cardec DM Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling ZoDen PD nasal spray bottles because the products are underdosed or have an incorrect dosage regime.
Whole Foods Market is recalling Curried Vegan Chick N Salad due to an undeclared soy allergen. The product was sold in six northeastern states.
TG United, Inc. is recalling Mesehist WC cough and cold medicine due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
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.
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 1,623 bottles of Maxifed-G tablets because the products are underdosed or have an incorrect dosage regime.
Medtronic is recalling NIM TriVantage EMG Endotracheal Tubes because the cuff may leak during surgery, requiring re-inflation or replacement to maintain patient ventilation.
TG United, Inc. is recalling TL Hist DM antihistamine and decongestant products because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling Poly-Vent DM Tablets because the products are underdosed or have an incorrect dosage regime.
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 1,398 bottles of AMBI cough syrup in five states because the product is underdosed or has 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.
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.
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 Tri-Mix Injections because FDA inspections raised concerns about quality control and sterility assurance.
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.
Pentec Health is recalling Proplete 45-51 KG intraperitoneal nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
TG United, Inc. is recalling Lusair Liquid, an over-the-counter product, because it may be underdosed or have an incorrect dosage regime.
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.
The Compounding Shop is recalling Methotrexate 25mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
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.
LL Bakery is recalling specific breads and pastries because the labels fail to declare milk as an allergen.
The Compounding Shop is recalling MIC + B12 injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
The FDA is recalling 2,716 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially causing components to enter the patient's cavity.
The Compounding Shop is recalling Betamethasone 6 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The Compounding Shop is recalling Baclofen 1,000 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
TG United, Inc. is recalling Dallergy Chewable Tablets because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling BroveX PSE DM bottles because they are underdosed or have an incorrect dosage regime.
Pentec Health is recalling Proplete 34-39 KG intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
TG United, Inc. is recalling 352 bottles of AMBI 25DPH/7.5PEH Antihistamine, Nasal Decongestant due to CGMP deviations resulting in underdosed products.
Pentec Health is recalling Proplete 80+ KG renal nutritional prescriptions because sterility could not be assured for the compounded sterile products.
Pentec Health is recalling Baxter LL bag 1.5% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
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.
TG United, Inc. is recalling Cardec Drops nasal decongestant because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling 40,149 bottles of Trigofen DM 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.
TG United, Inc. is recalling BroveX PSE antihistamine and nasal decongestant tablets 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.
Pentec Health is recalling 38 bags of Proplete 70+ KG renal nutritional solution because sterility could not be assured for the compounded product.
Hospira Inc. is recalling 44,748 bags of Dobutamine in Dextrose Injection because a confirmed leak in the primary container raises concerns about sterility.
Hill-Rom, Inc. is recalling 8,737 Hill-Rom 1000 Beds because brakes may disengage when the bed frame is subjected to a hard jolt or force.
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 specific lots of Trigofen Drops because the products are underdosed or have an incorrect dosage regime.
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.
The Compounding Shop is recalling B-Complex 100 mg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
TG United, Inc. is recalling Z-Dex Pediatric Drops because the products are underdosed or have an incorrect dosage regime.
Symbios Medical Products is voluntarily recalling GoPump infusion pumps and kits due to reports of excessively high flow rates.
Chemi-Source Inc. is recalling 1,320 units of 100% Micellar Casein powder because the milk ingredient was not listed as an allergen.
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.
Chemi-Source Inc is recalling All Natural Gainer Chocolate protein powder because the milk ingredient was not listed on the label.
Alcon is removing 8,455 Constellation Pneumatic Handpieces from the market because forceps or scissors tips may dislodge if not attached according to instructions.
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.
Chemi-Source Inc. is recalling MRM All Natural Whey Dutch Chocolate products because the whey ingredient was not listed as milk, a major allergen.
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.
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.
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.
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.
Cordis is recalling 784 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.
American Optisurgical is recalling ChloraPrep Hi-Lite Orange 3mL Applicators because an incomplete seal on the packaging may have compromised sterility assurance.
Cordis Corporation is recalling 250 units of FLEXSTENT stent systems because holes or tears can form in the protective pouches.
Chemi-Source Inc is recalling Low Carb Protein products because the whey ingredient is 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.
Stryker is recalling T4 Toga sterile surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
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 All Natural Whey protein products because the milk allergen was not listed on the label.
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.
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.
Chemi-Source Inc is recalling Isolate Whey Protein Chocolate Malt because the whey ingredient was not listed as milk, a major allergen.
The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter the patient's cavity.
Chemi-Source Inc. is recalling 2,932 units of 100% Micellar Casein (Rich Chocolate) because the milk ingredient was not listed as an allergen.
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.
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.
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.
Cordis Corporation is recalling 310 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.
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.
Chemi-Source Inc is recalling Sprouts Farmers Market Whey Protein Chocolate because the whey ingredient was not listed as milk, a major allergen.
TG United, Inc. is recalling 886 bottles of AMBI 40PSE/400GFN tablets because the products are underdosed or have an incorrect dosage regime.
GE Healthcare is recalling 800 reusable CO2 absorbent canisters used with anesthesia systems because they may not seal properly.
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.
Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Chemi-Source Inc. is recalling 1,182 units of Micellar Casein powder because the milk ingredient was not listed as an allergen.
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.
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.
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