The Food and Drug Administration announced today that medical device maker and distributor, Invacare Corp., and two of its top executives have signed a consent decree of permanent injunction requiring the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components.
P&J Trading Issues a Voluntary Recall of All Lots of the Dietary Supplements Slimdia Revolution
Dietary Supplements
Voluntary Product Recall Initiated by Qualitest Pharmaceuticals Impacts Three Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Repackaged and Distributed by Mylan Institutional
Mylan Inc. (Nasdaq: MYL) today announced that its Mylan Institutional business is conducting a voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573). The three lots were manufactured by Qualitest Pharmaceuticals, and Mylan Institutional repackaged and distributed the product in unit dose (CD100) under the UDL Laboratories, Inc. (n/k/a Mylan Institutional Inc.) label.
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.
FDA permits marketing of device to seal lung punctures
The U.S. Food and Drug Administration today allowed marketing of the Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by biopsies performed to confirm a diagnosis of suspected lung conditions.
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 almonds run the risk of a serious or life-threatening allergic reaction if they consume these products.
FDA warns against improper advertising, promotion of lasers intended for LASIK corrective eye surgery
The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.
True Taste, LLC RECALLS, "Hot Smoked Rainbow Trout, Hot Smoked Whitefish, Hot Smoked Herring, Hot Smoked Mackerel, Hot Smoked Salmon Steak, Cold Smoked Mackerel, and Cold Smoked Whitefish"
True Taste, LLC of Kenosha, WI, is recalling it’s vacuum packaged Hot Smoked Rainbow Trout, Hot Smoked Whitefish, Hot Smoked Herring, Hot Smoked Mackerel, Hot Smoked Salmon Steak, Cold Smoked Mackerel, and Cold Smoked Whitefish because they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life- threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
Matrixx Initiatives Issues Nationwide Voluntary Recall of One Lot of Zicam®
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.
Recall – Performance Plus Marketing Press Release
December 17, 2012 – Performance Plus Marketing, Inc. Issues a Voluntary Nationwide Recall of Libigrow®, Libigrow XXXtreme®, Blue Diamond®, Blue Diamond Platinum®, Mojo Nights®, Mojo Nights Supreme®, and Casanova® because they contain undeclared Sulfoaildenafil and Thioaildenafil. Performance Plus Marketing, Inc. has been informed by the US Food and Drug Administration (FDA) that FDA lab analysis of Mojo Nights® distributed by the company was found to contain undeclared sulfoaildenafil and thioaidenafil, which are analogues of sildenafil.