FDA/CMS parallel review process makes test for efficient identification of multiple targeted therapy options available to health care professionals, patients and eligible Medicare beneficiaries sooner
Virginia Diner, Inc. Issues Allergy Alert on Undeclared Peanut Allergen in Chocolate Covered Cashews 10 oz. cans
Virginia Diner, Inc. is voluntarily issuing a recall of 10 oz. cans of Plow & Hearth Chocolate Covered Cashews at Plow & Hearth’s locations and nationwide (Mail Order) as a precaution because they may contain peanuts and peanut allergens. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. A label mix up was discovered by a consumer who received and opened a Cashew Tower Set (3 individual cashew cans) of which one can, the 10 oz. Chocolate Covered Cashews, were found to have Salted Peanuts.
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Nutra Labs Inc. Issues Voluntary Nationwide Recall of Dietary Supplements Bull and Chao Jimengnan Tablets Due to Undeclared Active Pharmaceutical Ingredients
Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800 mg Capsules with the production date of 05/08/2016, and Chao Jimengnan 150 mg Tablets with Lot # 20151018 to the consumer level. FDA analysis found the products to be tainted with sildenafil, 0.026mg/capsule for Bull, and 70.46mg/tablet for Chao Jimengnan respectively. Sildenafil is the active pharmaceutical ingredient in an FDA approved product used for erectile dysfunction, making Bull capsules and Chao Jimengnan tablets unapproved new drugs.
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH"
FDA Commissioner Gottlieb provides testimony before the House Committee on Energy and Commerce on the agency’s implementation of the 21st Century Cures Act
Farrell Farms, Inc. Issues allergy alert on undeclared milk in Dark Chocolate Almonds, Dark Chocolate Cashews, and Dark Chocolate Pecans
Farrell Farms, Inc. of Goldsboro, NC is recalling 7 oz Dark Chocolate Almonds, 7 oz Dark Chocolate Cashews, and 7 oz Dark Chocolate Pecans, because these products may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Leclerc Foods Issues Limited Voluntary Recall of Fit & Active Chocolatey Chip Protein Meal Bars – Due to Presence of Plastic Piece
Leclerc Foods has initiated a limited voluntary recall of a single lot of Fit & Active Chocolatey Chip Protein Meal Bars packages with UPC Code 41498-18695 and only affected products with a “best by” date of May 24, 2018.
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Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet® (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer due to Microbial Contamination
Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies) is voluntarily recalling two lots of Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall). This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis). The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval.
Food Co. Issues Allergy Alert on Undeclared Allergen (E.G. Milk) in Product
Colorado Nut Company of Denver, CO is recalling Cashew Cranberry Cherry Jubilee, Oat Bran Nutty Crunch, Honey Nutty Granola, Peanut Delight, and Frontier Trail Mix, because they may contain undeclared Milk. People who have an allergy or severe sensitivity to Milk run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients
FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.
FDA approves first two-drug regimen for certain patients with HIV
FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment.