CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspectional findings of deficiencies in the Quality System regulations for Medical Device Manufacturers, 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The Viscoelastic products, intended for human and animal use, have been determined to be a public health concern due to distribution in the US without FDA approval, which evaluates the safety and efficacy of the product, and violations of the QSR regulations related to sterility, and biocompatibility that may result in the release of contaminated products.
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Jayone Food Issues Voluntary Alert on Undeclared Peanuts in Dried Seaweed Salad
Jayone Foods, inc. of Paramount, CA is voluntarily recalling All date codes of Trader Joe’s Dried Seaweed Salad with Spicy Dressing (SKU 97677), because it may contain traces of peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA approves new treatment for hepatitis C virus
The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.
FDA approves first adjuvanted vaccine for prevention of H5N1 avian influenza
The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus.
FDA approves Nexavar to treat type of thyroid cancer
The U.S. Food and Drug Administration today expanded the approved uses of Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer.
Marina’s German Bakery Issues Allergy Alert on Undeclared Almonds, Walnuts, and Hazelnuts in Pastry Products
Marina’s German Bakery of El Paso, Texas is recalling two-count packages of pastry products, because they may contain undeclared Almonds, Walnuts, or Hazelnuts. People who have an allergy or severe sensitivity to Almonds, Walnuts, or Hazelnuts run the risk of serious or life threatening allergic reaction if they consume these products.
The two count packages of Assorted Pastries were distributed in El Paso,Texas at Fort Bliss Commissary and in Alamogordo, New Mexico at Holloman AFB Commissary.
Deseo Rebajar Inc. Issues Voluntary Puerto Rico Recall of Adipotrim XT Due to Underclared Fluoxetine
Deseo Rebajar Inc., is voluntarily recalling lot #052012 of Adipotrim XT to the consumer level. The FDA laboratory analysis of this dietary supplement found to contain undeclared Fluoxetine.
FDA allows marketing of four “next generation” gene sequencing devices
Today the U.S. Food and Drug Administration allowed marketing of four diagnostic devices that can be used for high throughput gene sequencing, often referred to as “next generation sequencing” (NGS). These instruments, reagents, and test systems allow labs to sequence a patient’s DNA (deoxyribonucleic acid).
Tendex Issues Voluntary Nationwide Recall of P-Boost, NatuRECT Due to Undeclared Active Ingredients
Los Angeles, CA Tendex is voluntarily recalling Lot# F51Q of P-Boost and Lot # F51Q of NatuRECT to the consumer level. FDA laboratory analysis on Lot# F51Q of P-Boost, which the firm also labels as NatuRECT, has determined that this product contains undeclared tadalafil.
Recall expanded to include: Raspberry Lemonade OxyELITE Pro Super Thermo Powder
USPlabs LLC, Dallas, TX is voluntarily conducting a national recall of all lots and sizes of the OxyElite Pro dietary supplement products listed below.
These products contain Aegeline, a synthesized version of a natural extract from the Bael tree.