Hospira, Inc., a Pfizer company, has announced a
voluntary recall of one lot of, MAGNESIUM SULFATE IN WATER FOR INJECTION
(0.325 mEq Mg**/mL) 40 mg/mL 2g total, 50 mL (NDC: 0409-6729-24, Lot 53-113-JT,
Expiry 1NOV2016) to the user level due to a confirmed customer report of an incorrect
barcode on the primary bag labeling. The product has a barcode identifying the product
contents on both the overwrap and on the primary container. The barcode on the
overwrap is correct; however, there is potential for the primary container barcode to be
mislabeled with the barcode for HEPARIN SODIUM 2000 USP UNITS/1000 mL in
0.9%SODIUM CHLORIDE INJECTION.
Category Archives: Food & Drug Recalls
Baxter Initiates Voluntary Recall of Two Lots of IV Solutions due to Potential Presence of Particulate Matter
Baxter International Inc. announced today it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint.
Big Dog Natural Recalls Chicken and Fish Supreme Dog Food Due to Possible Salmonella and Listeria monocytogenes Health Risk
Big Dog Natural of Brick, NJ is voluntary recalling a select production lot of Big Dog Natural raw dehydrated dog food Chicken Supreme potentially contaminated with Salmonella and Fish Supreme potentially contaminated with Listeria monocytogenes that was shipped in the week of 10/31/2015 to 11/13/2015 to online customers. Salmonella and Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks
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.
FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks
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.
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 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.