Tendex has recalled Lot# F51Q of P-Boost and Lot # F51Q of NatuRECT after FDA laboratory analysis on Lot# F51Q of P-Boost, which the firm also labels as NatuRECT, found that it contained undeclared tadalafil. Tadalafil is an active ingredient of FDA-approved drugs used to treat erectile dysfunction (ED), making these products unapproved drugs. The … [Read more...]
CLR Medicals International Inc. Recalls Viscoelastic Products
CLR Medicals International Inc. is recalling Viscocel and Viscocel Plus. This drug recall is in response to FDA 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 … [Read more...]
FDA Classifies Stryker Corp. Shapematch Cutting Guides Recall as Class I
Stryker Corporation (NYSE:SYK) announced today that its orthopaedic division has received notice that the U.S. Food and Drug Administration (FDA) has reviewed the voluntary recall of its ShapeMatch Cutting Guides and that it will be classified as a Class I recall. ShapeMatch Cutting Guides are intended to be used as patient specific surgical … [Read more...]
DZH Import & Export Inc. issues an alert on undeclared sulfites in Curiosity OfDashan Dried Mushroom
DZH Import & Export Inc. at 1300 Metropolitan Avenue, Brooklyn NY 11237 is recalling CURIOSITY OF DASHAN DRIED MUSHROOM because it contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product. The recalled CURIOSITY OF DASHAN DRIED … [Read more...]
Bunnell Incorporated Recalls Life Pulse High-Frequency Ventilator Patient Circuits
Contact: Consumer: 1-800-800-4358 ext. 6 plattdr@bunl.com Bunnell Incorporated has recalled Life Pulse High-Frequency Ventilator Patient Circuits. A complete list of Lot numbers affected by the recall is identified in the recall notice and on Bunnell's website, www.bunl.com. The product has been found to have heater wire insulation that can melt, … [Read more...]
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