FDA Alerts
Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients
Pentec Health, Inc. has decided to initiate a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. The recall covers renal therapies that were compounded in this hood on or before May 2, 2013.
Tropical Valley Foods Issues Allergy Alert on Undeclared Milk and Walnuts in Next by Nature Dark Chocolate Bananas
Tropical Valley Foods Inc. of Plattsburgh, NY, is recalling next by Nature DARK CHOCOLATE BANANAS, 3 oz. bags, due to undeclared milk and walnuts. People who have an allergy to milk and/or walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.
Rural King Recalls Deer Corn Because of Possible Health Risk
Rural King Distributing of Mattoon, IL is recalling 205 tons of Deer Corn, because it has the potential to be contaminated with aflatoxin. Aflatoxin is a naturally occurring mold by-product.
Symbios Medical Products Issues Nationwide Recall of GOPump and GOBlock Kits
May 10, 2013 - Symbios Medical Products initiated a voluntary recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. These products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age.
Additional Lots Added: Voluntary Nationwide Recall of 21 Lots of Piperacillin and Tazobactam for Injection, USP 40.5 Grams Due to Possibility of Precipitation / Crystallization in IV Bag or IV Line Upon Reconstitution
May 10, 2013 – Weston, Florida: Apotex Corp. announced today that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider /user level. The impacted lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in IV bag or IV line after reconstitution.
Beamonstar Products Issues Voluntary Nationwide Recall of SexVoltz, Velextra, & Amerect Marketed as a Dietary Supplement, Due to Undeclared Active Ingredients- Expanded to Include SexVoltz 12 Capsules Bottle, SKU 626570615316.
Queen Creek, AZ, BeaMonstar Products is voluntarily recalling all of SexVoltz brand SKU’s 626570609490, 827912089028, 626570617877, 626570615316, 626570615316 Velextra brand SKU’s 626570613855, 626570619055, 626570617860, 626570617563 Amerect SKU’s 626570619031, 626570619628 capsules to the consumer level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the products unapproved new drugs.
Hannaford Supermarkets Issues Allergy Alert for Two Bakery Cookie Products That May Contain Undeclared Nuts
Hannaford Supermarkets is recalling two products sold in the bakery section because they may contain nuts that are not listed on the product packaging label. Individuals who have an allergy or severe sensitivity to any nuts may run the risk of serious or life-threatening allergic reaction should they consume these items.
