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Trends In FDA FY2022 Inspection-based Warning Letters

Trends In FDA FY2022 Inspection-based Warning Letters

FDA to Withdraw Temporary Hand Sanitizer Production Policies

FDA to Withdraw Temporary Hand Sanitizer Production Policies
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MIL-OSI USA: Medically Minded Hand Sanitizer– Nationwide Recall Expansion Due to The Presence of Undeclared Methanol

Medically Minded Hand Sanitizers: 8.5 oz. UPC 676753004147; Lot E372020 10 oz. UPC 676753004178 Lot GV4420205 This recall has been initiated due to the presence of undeclared Methanol. Use of or consumption of this product can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma & or permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. Methanol was discovered through lab testing. To date, Global Sanitizers has not received any reports of adverse events related to this recall.

Recall Expanded For Medically Minded Hand Sanitizer

Recall Expanded For Medically Minded Hand Sanitizer WASHINGTON (dpa-AFX) - Las Vegas, Nevada-based Global Sanitizers has expended its recall of Medically Minded Hand Sanitizer citing the presence of undeclared methanol, the U.S. Food and Drug Administration said. The recall now includes 8 oz. Sanitizers with UPC 676753004208; Lot E332020, Lot E212020, and Lot E082020; 8.5 oz. sanitizers with UPC 676753004147; Lot E372020; as well as 10 oz. sanitizers with UPC 676753004178 Lot GV4420205. All these lots have Best By Date of 5/21/2022, and the company began shipping these products on approximately July 10, 2020. In early May, the company had called back 50 thousand units of Medically Minded hand sanitizers with lot numbers: E212020 & E082020 Best Buy of 5/21/2022 to the user/consumer level. These sanitizers were packaged in 8.5 oz / 250 ml clear bottles with caps with UPC 7675300359.

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