This recall press release was issued by the firm on 06-23-2020 and is subsequently being posted by FDA at this time only to benefit the public for informational purposes. Human Consumption (MHR Brands) Tasty Drops – Berry Tincture, 1oz/300mg FG003175 Tasty Drops – Berry Tincture, 1oz/500mg FG003137 FG003174, FG003197, FG0057 Tasty Drops – Berry Tincture,…
Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
Summary Company Announcement Date: July 14, 2020 FDA Publish Date: July 14, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Methanol Contamination Company Name: Soluciones Cosmeticas Brand Name: Brand Name(s) Product Description: Product Description Hand Sanitizer Gel Company Announcement Soluciones Cosméticas is voluntarily recalling all lots of Bersih Hand Sanitizer Gel Fragrance…
AAA Cosmética, S.A. de C.V. Issues Voluntary Nationwide Recall of all Lots Within Expiry of bio aaa Advance Hand Sanitizer 480 mL Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
Summary Company Announcement Date: July 14, 2020 FDA Publish Date: July 14, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Undeclared Methanol Contamination Company Name: AAA Cosmetica, S.A. de C.V. Brand Name: Brand Name(s) Product Description: Product Description Hand Sanitizer Company Announcement AAA Cosmética, S.A. de C.V. is voluntarily recalling all lots…
4e Brands North America Issues Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
BLUMENAdvancedInstant HandSanitizerClear 60599-015-00 33.8 fl oz / 1L 814266023747 2213, 2219, 2220, 2221, 2223, 2225, 2252, 2255,2226, 2227, 2254, 2467,2244, 2247, 2229, 2845,2847, 2212, 2217, 2222,2250, 2249, 2463, 2465,2676, 2678, 2846, 2216,2228, 2399, 2464, 2466,2684, 2246, 2259, 2675,2683, 2218, 2245, 2231,2258, 2202, 2215, 2224,2441, 2251, 2230, 2681,2256, 2257, 2679, 2682 BLUMENAdvancedHandSanitizer 60599-012-04 7.5 fl oz/…
Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Summary Company Announcement Date: July 03, 2020 FDA Publish Date: July 06, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitrosodimethylamine (NDMA) Company Name: Granules Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets USP, 750 mg Company Announcement Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve…
Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Summary Company Announcement Date: July 08, 2020 FDA Publish Date: July 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitrosodimethylamine (NDMA) Impurity Company Name: Lupin Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Company Announcement Lupin Pharmaceuticals Inc. is voluntarily recalling all batches…
Endologix Issues Correction Notice for Ovation iX Abdominal Stent Graft System
Summary Company Announcement Date: June 15, 2020 FDA Publish Date: July 08, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Company Name: Endologix® Inc. Brand Name: Brand Name(s) Product Description: Product Description Ovation iX system…
CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets
Summary Company Announcement Date: July 03, 2020 FDA Publish Date: July 08, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Use of the pump system potentially could cause over-infusion or under-infusion of therapy Company Name: CME America Brand Name: Brand Name(s) Product Description: Product Description Infusion System Administration Set (infusion set) Company…
Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate
Summary Company Announcement Date: July 07, 2020 FDA Publish Date: July 07, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter Company Name: Mylan Institutional LLC Brand Name: Brand Name(s) Product Description: Product Description Daptomycin for Injection Company Announcement Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional…
False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System – Letter to Clinical Laboratory Staff and Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found approximately three percent (3%) of results were false positive results. Recommendations The FDA recommends…