After a new study linked Depakote and other valproate medications taken during pregnancy to an increased risk of autism and autism spectrum disorders, the FDA has decided to put its strongest warning for pregnancy associated complications on the drug, designating … Continued
Drug Recalls
Pharmaceutical industry recall news and information about recalled drugs and defective medical devices, including recalls coming from Food and Drug Administration (FDA) press releases.
FDA Struggles to Prevent Recurrence of Meningitis Outbreak
On May 9, the FDA warned that unless it gets additional authority to regulate compounding facilities, we will likely see a recurrence of the multistate meningitis outbreak that killed nearly 50 people and sickened more than 700. In the meantime, … Continued
FDA Warns of the Dangers of DMAA (Dimethylamylamine)
The FDA has warned consumers not to take any dietary supplement containing the ingredient DMAA (dimethylamylamine, which goes by other names as well, listed below), which has been associated with numerous risks, including seizures, heart attack, and death. When asked … Continued
FDA Classifies Stryker Corp. Shapematch Cutting Guides Recall as Class I
Stryker Corporation (NYSE:SYK) announced today that its orthopaedic division has received notice that the U.S. Food and Drug Administration (FDA) has reviewed the voluntary recall of its ShapeMatch Cutting Guides and that it will be classified as a Class I … Continued
DZH Import & Export Inc. issues an alert on undeclared sulfites in Curiosity OfDashan Dried Mushroom
DZH Import & Export Inc. at 1300 Metropolitan Avenue, Brooklyn NY 11237 is recalling CURIOSITY OF DASHAN DRIED MUSHROOM because it contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions … Continued
Bunnell Incorporated Recalls Life Pulse High-Frequency Ventilator Patient Circuits
Contact: Consumer: 1-800-800-4358 ext. 6 plattdr@bunl.com Bunnell Incorporated has recalled Life Pulse High-Frequency Ventilator Patient Circuits. A complete list of Lot numbers affected by the recall is identified in the recall notice and on Bunnell’s website, www.bunl.com. The product has … Continued
Qualitest Issues Nationwide Recall of 101 Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, Usp 10 Mg/500 Mg Due to the Potential for Oversized Tablets
Contact: Consumer: 1-800-444-4011 Media: Blaine Davis 1-610- 459-7158 FOR IMMEDIATE RELEASE December 6, 2012 – Qualitest, a subsidiary of Endo Health Solutions, (Nasdaq: ENDP) today issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP … Continued
LifeVantage Corporation Announces Voluntary Recall and Replacement of Select Lots of Protandim® Dietary Supplement Due to Potential Health Risk
Salt Lake City, (GLOBE NEWSWIRE) – LifeVantage Corporation (NASDAQ: LFVN) announced today that it is contacting affected independent distributors and other customers to voluntarily recall and replace bottles of its Protandim®, the Nrf2 Synergizer®, dietary supplement from the lots shown … Continued
Hospira Issues Voluntary Nationwide Recall of Three Lots of Carboplatin Injection Due to Visible Particulate Matter
Lake Forest, Ill – Hospira, Inc. (NYSE: HSP), issued this press release today to further inform the general public about a previously communicated voluntary user-level recall of three lots of Carboplatin Injection due to visible particulates identified during a retain … Continued
Matrixx Initiatives Issues Nationwide Voluntary Recall of One Lot of Zicam® Extreme Congestion Relief Due to Contamination With Burkholderia Cepacia
Matrixx Initiatives is voluntarily recalling 1 lot of Zicam® Extreme Congestion Relief nasal gel. The company is taking this step after finding a small amount of Burkholderia cepacia in a single sample of the product taken from the affected lot. … Continued
Udi’s Healthy Foods, LLC Issues Allergy Alert for Undeclared Almonds in 12-ounce “Udi’s Gluten Free Au Naturel Granola”
Udi’s Healthy Foods, LLC of Denver, Colorado, is voluntarily recalling its 12-ounce bags of “Udi’s Gluten Free Au Naturel Granola” with UPC 6-98997-80615-8 and “Best By 041913 12265 1″ because they may contain undeclared almonds. People who are allergic to … Continued
Performance Plus Marketing Recalls Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, Casanova Supplements
Performance Plus Marketing, Inc. is recalling Libigrow®, Libigrow XXXtreme®, Blue Diamond®, Blue Diamond Platinum®, Mojo Nights®, Mojo Nights Supreme®, and Casanova® because they contain undeclared Sulfoaildenafil and Thioaildenafil.
P&J Trading Recalls All Lots of the Dietary Supplements Slimdia Revolution
P&J TRADING is conducting a voluntary nationwide recall of their dietary supplements sold under the brand name SLIMDIA REVOLUTION specific to the following product below. There is no identifying lot number.
Praxair, Inc. Recalls Grab ‘n Go Vantage Portable Oxygen Cylinder Units
Praxair, Inc. is in the process of conducting a voluntary recall involving Grab ‘n Go Vantage portable oxygen cylinder units. Praxair is making a minor modification to the affected units as they come in for routine servicing and filling. Praxair … Continued
Qualitest Pharmaceuticals Recall: Three Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Distributed by Mylan Institutional
Mylan Inc. announced that its Mylan Institutional business is recalling three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573).
Zimmer Spine Issues Urgent Worldwide Medical Device Recall Of The Inserter Instrument For The PEEK Ardis Interbody Spacer
Zimmer Spine, Inc. is initiating a voluntary worldwide recall of all 315 units of the PEEK Ardis® Inserter. The Ardis Inserter is a surgical instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer. The inserters are being … Continued
Mobius Therapeutics, LLC Issues a Voluntary Recall of Mitosol® (mitomycin forsolution), 0.2 mg/vial, Kit for Ophthalmic Use
Mobius Therapeutics, LLC, St. Louis, MO, announced today that it is conducting a voluntary recall of 2 lots of Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use. The company is taking this voluntary action due to the fact … Continued
FDA Warns Durata Quality Control Problems Could Lead to Fines or Worse for St. Jude
Last week, the FDA warned manufacturer St. Jude that quality control and design problems related to the Durata ICD lead must be resolved within 15 days from the date of the letter (January 10) or the firm would face additional … Continued
Advance Pharmaceutical Rcalls One Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, that may actually contain Meclizine HCl 25 mg tablets
Advance Pharmaceutical Inc. today announced that it is conducting a voluntary nationwide recall of one lot of Ferrous Sulfate Tablets, 325 mg, Lot 12G468 Exp. 07/14, UPC Barcode 0 0536-5890-01 3. The lot was manufactured and packaged in 100 count … Continued
Voluntary Worldwide Field Corrective Action Issued for the T-piece Circuit used on GE Healthcare’s Giraffe and Panda
GE Healthcare initiated a voluntary worldwide field correction of the T-piece circuit used with GE Healthcare’s Giraffe and Panda resuscitation units. The T-piece circuits affected by this recall are sold under the following part numbers and contain a red inspection … Continued