American Regent is conducting a nationwide voluntary recall to the Retail/Hospital level of the following product:
Epinephrine Injection, USP, 1:1000, 1 mL Ampules NDC #0517-1071-25 Lot #1395, Exp Date: July 2012
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FDA strengthens international collaboration to ensure quality, safety of imported products
The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report” [INSERT HYPERLINK], detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.
Report: FDA strengthens monitoring of post-approval drug safety
A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public, according to a new report released today by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to postmarket drug safety monitoring as to premarket drug review.
XROCK INDUSTRIES, LLC Issues a Voluntary Nationwide Recall of X-ROCK, a Product Marketed as a Dietary Supplement To Support Male Sexual Performance, Due to Unlisted, Potentially Hazardous Ingredient
XROCK INDUSTRIES, an independent distributor of the X-ROCK products, is conducting a user level voluntary recall of certain supplement products sold by XROCK INDUSTRIES under the brand name of X-ROCK. Finished product of X-ROCK for Men was tested and preliminarily found to contain an analogue of an ingredient in an FDA-approved drug.
FDA issues draft guidance on nanotechnology
Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.
U.S. Marshals seize ultrasound gel product at a New Jersey company
U.S. Marshals, acting at the request of the Food and Drug Administration, today seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J. after an FDA analysis found that product samples contained dangerous bacteria.
Hong Lee Trading Inc. Issues An Alert On Undeclared Sulfites In Peacock Brand Preserved Apricots
Hong Lee Trading Inc., 225 Johnson Ave., Brooklyn, NY 11203 is recalling Peacock Brand Preserved Apricots because it may contain undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
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M.E. Thompson, Inc. Expands Recall of Sub Sandwiches Because of Possible Health Risk
M.E. Thompson, Inc. is expanding the recall of its Anytime Deli Turkey & Ham Footlong, to include Italian Footlong, and Classic Cuban, because the products have the potential to be contaminated with Listeria Monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea.
Hospira Announces a Nationwide Voluntary Recall of One Lot of Morphine Sulfate Injection, USP 4 MG/ML, (C-II) 1 ML Fill in 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume
Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary user level recall of one lot of Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1258-30, due to a customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume. Opioid pain medications such as morphine have life-threatening consequences if overdosed.Â
Notice of Recall
Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and instituted a recall. The recall involved five physicians and seven prescriptions. The physicians have been contacted and all prescriptions accounted.