The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
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Pharmedium Issues Voluntary Nationwide Recall of 4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag for Discoloration.
Lake Forest, IL PharMEDium Services, LLC is voluntarily recalling 29 lots of 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 3 lots of 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag distributed to hospital customers. We have received complaints from hospitals for products that have been found to exhibit a slight discoloration in the admixture.
Thomas Produce Recalls Cucumbers because of Possible Health Risk
Thomas Produce Company of Boca Raton, FL is recalling 174 bulk-packed containers of Cucumbers. This product 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.
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Uoriki Fresh, Inc. Recalls "Octopus Salad" Because of Possible Health Risk
Uoriki Fresh, Inc. (UF) of Secaucus, NJ is recalling its “Octopus Salad”, because it has the potential to be
contaminated with Listeria monocytogenes (LA1) , an organism which can cause serious and sometimes fatal
infections in young children, frail or elderly people, and others with weakened immune systems. Although
healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffuess,
nausea, abdominal pain and diarrhea. Listeria infection can also cause miscarriages and stillbirths among
pregnant women.
Taylor Farms Pacific, Inc. Recalls Signature Cafe Traditional Stuffing Due to Potential Undeclared Allergens
Taylor Farms Pacific, Inc. of Tracy, California is voluntarily recalling 190 cases of Signature Cafe Traditional Stuffing because the product label did not identify certain ingredients including soy, milk and wheat. The recalled product was sold in a limited number of Safeway and Pak ‘N Save stores in Northern California and Nevada and Vons stores in Fresno, CA; Clovis, CA and Oakhurst, CA.
Nuway Distributors llc Issues Voluntary [Worldwide/Nationwide] Recall of APEXXX Due to Presence of Undeclared Sildenafil
Nuway Distributors llc is voluntarily recalling all lots of APEXXX tablets to the consumer level. FDA analysis found APEXXX to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug.
Nuway Distributors llc Issues Voluntary [Worldwide/Nationwide] Recall of APEXXX Due to Presence of Undeclared Slidenafil
Nuway Distributors llc is voluntarily recalling all lots of APEXXX tablets to the consumer level. FDA analysis found APEXXX to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug.
American Pure Whey Issues Allergy Alert on Undeclared Milk and Soy in Whey Protein Products.
American Pure Whey, New Bern, NC is recalling all lots distributed from 7/2015 to 09/2015 of the products 100% Pure Whey Protein Matrix and 100% Pure Whey Protein Isolate, because they may contain undeclared milk and soy that are present in the whey ingredient. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life threatening allergic reaction if they consume these products.
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Urgent: Drug Recall – Weight Loss Dietary Supplements with Undeclared Sibutramine and Phenolphthalein
Under the brands: La’ Trim Plus, Jenesis and Oasis, all lots and expiration dates.Recent Analysis by the Food and Drug Administration has found undeclared Sibutramine and Phenolphthalein in the Dietary Supplement “La’Trim Plus”, “Oasis”, and “Jenesis”.
Bee Extremely Amazed LLC Issues Voluntary Nationwide Recall of Various Products Distributed For Weight Loss Due to Undeclared Drug Ingredients
Bee Extremely Amazed LLC, Jewett, OH is voluntarily recalling various products marketed for weight loss to the consumer level due to findings of undeclared drug ingredients including sibutramine and/or phenolphthalein.