FDA Recalls

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 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 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.

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.

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.

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 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.

Smart & Final of Los Angeles, Calif., which previously announced a recall of certain production dates of 2.5 lb - La Romanella Tri-Color Cheese Tortellini, is expanding its recall to include additional production dates due to undeclared wheat, eggs and milk. People who have an allergy or severe sensitivity to wheat, eggs and/or milk run the risk of serious or life-threatening allergic reaction if they consume these products.

The Compounding Shop, LLC is conducting a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Krinos Foods, LLC. of Long Island City, New York is voluntarily recalling its TAHINI sesame paste, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Dairy Fresh is voluntarily recalling a specific batch of IGA Brand “Vanilla & Chocolate” Ice Cream (1.75 quart, 1.66L) with the plant code “3783” and a SELL BY date of 08-13-13 because it incorrectly contains Heavenly Hash ice cream, which contains almonds, coconut, and soy, which are allergens not declared on the carton. People who have an allergy or severe sensitivity to almonds, coconut, or soy run the risk of serious or life-threatening allergic reaction if they consume this product.

May 9, 2013 - CAMBRIDGE, MA. – Whole Foods Market is recalling bulk curried chicken salad and bulk vegan curried chick'n salad because in some stores these items may have been sold with reversed labels causing undeclared soy and egg allergens. Due to the label mix-up, allergens were undeclared; the vegan chick'n salad contains soy, and the curried chicken salad contains egg.

Today, Pure Herbs Ltd., Sterling Heights, MI is voluntarily recalling the 4oz and 1oz bottles of Protein Extract because they contain undeclared allergens - milk and soy. This labeling error was discovered during a routine Food and Drug Administration (FDA) inspection when a review of the ingredients found that milk and soy allergen ingredients were not listed on our main label.

Bimeda Inc., on behalf of the manufacturer, Bimeda-MTC Animal Health Inc. is voluntarily recalling one lot of Calcium Gluconate, one lot of Dextrose 50%, and one lot of Hypertonic Saline, all of which are in the form of injectable fluids, to the user level. These injectable fluids are being recalled as a precautionary measure; because of departures from customary sterility procedures, sterility cannot be entirely assured.

Nutraceutical company XYMOGEN in Orlando, Fla., is recalling artriphen, a product recommended for the support of healthy joint function, because it contains traces of the undeclared allergens soy and milk.

Queen Creek, AZ, BeaMonstar Products is voluntarily recalling all of SexVoltz brand SKU’s 626570609490, 827912089028, 626570617877, 626570615316, Velextra brand SKU’s 626570619475, 626570619475, 626570619475, 626570619475 , Amerect SKU’s 626570619031, 626570619598 capsules to the retail 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.

2013 Chang Kwung announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand name Lightning Rod 500 mg per capsule packaged in 3-count, UPC 6 89076 20257 2 and 12-count bottles, UPC 6 89076 20297 8. Chang Kwung is conducting a voluntary recall after being notified by the US FDA that analytical testing found the Lightning Rod Capsules to contain an analogue of Sildenafil.

Cargill’s animal nutrition business today announced a voluntary recall of Showmaster® S-Series Show Lamb Feed (BW) because it contained incorrect sodium molybdate levels. To date, there are 170, 50-pound bags of feed still out in the market.

Nestlé USA’s Pizza Division today announced the voluntary recall of select production codes of four different frozen pizzas sold in the U.S. These include: • California Pizza Kitchen (CPK) Crispy Thin Crust White®, UPC 71921 98745; production codes are 3062525951, 3062525952 and 3063525951.

In keeping with its commitment to keep physicians informed about product performance and safety, Medtronic, Inc. (NYSE: MDT) issued an Urgent Medical Device Correction notification in February 2013 to provide physicians with information concerning the potential for deep brain stimulation (DBS) lead damage associated with the use of the lead cap provided in Medtronic DBS lead kits and dystonia therapy kits.