Milky Way International Trading Corp. today announced the recall of Nice! Mandarin Oranges in 8-ounce bottles due to potential glass in the product. The affected product was distributed to Walgreens stores nationwide and displays one of the lot numbers listed below. Consumers could potentially be cut or injured if ingested. To date there have been three complaints, and one alleged injury reported.
FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers
The U.S. Food and Drug Administration today approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.
Cape Cod Provisions LLC Issues Allergy Alert on Undeclared Almonds in Product
Cape Cod Provisions LLC of Pocasset, MA is recalling Cape Cod Cranberry Candy and Harvest Sweets Milk Chocolate/Dark Chocolate/Yogurt Covered Cranberry Blend (mix of all three varieties in the package) because they may contain undeclared yogurt covered almonds. These products can further be identified by their UPC codes; Cape Cod Cranberry Candy UPC 6 12681 10259 3 and Harvest Sweets UPC 6 12681 44259 0.
US Marshals seize dietary supplements containing kratom
The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.
The FDA engages stakeholders on opportunities to improve hearing aid usage and innovation
The U.S. Food and Drug Administration today announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States. The FDA will convene stakeholders for a public workshop and has re-opened a public comment period on a draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products (PSAPs).
Hospira Issues a Voluntary Nationwide Recall of One Lot of Magnesium Sulfate in Water for Injection Due to Incorrect Barcode Labeling on the Primary Container
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.
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.