FDA Alerts

Description	Publish Date
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.	5/17/2013 5:19:00 PM
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.	5/17/2013 3:54:00 PM
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.	5/17/2013 1:41:00 PM
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.	5/16/2013 7:49:00 PM
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.	5/11/2013 2:09:00 AM
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.	5/10/2013 8:53:00 PM
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.	5/10/2013 8:48:00 PM
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.	5/10/2013 8:00:00 PM
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.	5/9/2013 9:28:00 PM
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.	5/8/2013 9:19:00 PM
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.	5/8/2013 1:23:00 AM
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.	5/7/2013 5:52:00 PM
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.	5/6/2013 9:25:00 PM
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.	5/3/2013 1:16:00 PM
May 1, 2013 - American Lifestyle is announcing that it is conducting a voluntary recall of all lots of Vicerex UPC 893490820087 and Black Ant UPC 4026666142546. Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil.	5/2/2013 6:09:00 PM
WESTON, FL, April 26, 2013 /CNW/ - Apotex Corp. announced today that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 15 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.	4/29/2013 8:13:00 PM
Maple View Farm is voluntarily recalling pint containers of Cookies & Cream, Carolina Crunch and Cookie Dough ice cream because the products contain allergens that were not declared on package labels. Some or all of the products contain wheat,soy, almonds and peanuts, which can cause serious allergic reactions in people who have an allergy or sensitivity to these ingredients.	4/29/2013 6:26:00 PM
Hospira, Inc. (NYSE: HSP), announced today that last August it initiated a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, Flexible Container, NDC 0409-7984-23. This action was due to one confirmed customer report where four separate particulate issues were identified in four individual flexible containers.	4/26/2013 12:22:00 PM
Based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent. Cook received 13 complaints of delivery system tip separation with an occurrence rate of 0.043 percent.	4/25/2013 3:00:00 PM
On January 8, 2013, GE Healthcare initiated a nationwide voluntary field corrective action of the Giraffe Incubator with a Servo Control Oxygen System and Giraffe OmniBed, which were manufactured from August 1, 2012 through December 20, 2012. Giraffe Incubators without a Servo Control Oxygen System are not impacted.	4/23/2013 2:47:00 PM
Nora Apothecary & Alternative Therapies today announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013.	4/23/2013 2:44:00 PM
Balanced Solutions Compounding Pharmacy, LLC today announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired.	4/20/2013 4:27:00 PM
Covidien announced today that it notified customers on April 4, 2013, of a voluntary recall of certain Power Pac batteries for the Newport™ HT70 and HT70 Plus ventilators.	4/19/2013 12:46:00 AM
Abbott today announced it is initiating a voluntary recall of FreeStyle lnsulinx® Blood Glucose Meters in the United States. The company has determined that at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle lnsulinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result.	4/17/2013 4:34:00 PM
NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level. The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection.	4/16/2013 3:17:00 AM

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