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Safety Report: 光泽和清洁手部消毒液凝胶-因潜在存在甲醇(木醇)而召回, USA

4年前 source fda.gov

Recall notice

United States

Company name: Maquiladora Miniara, S.A. de C.V.
Brand name: Shine & Clean
Product recalled: Hand Sanitizer Gel
Reason of the recall: Potential presence of methanol (wood alcohol)
FDA Recall date: July 24, 2020
Recall details: Maquiladora Miniara S.A. de C.V. is voluntarily recalling lots of Shine and Clean Hand Sanitizer gel to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning Maquiladora Miniara S.A. de C.V. has not received any reports of adverse events related to this recall.

These products are used as topical hand sanitizers. The affected Shine and Clean Hand Sanitizer Gel is packaged in 1000 ml bottles and 1-gallon containers. Shine and Clean Hand Sanitizer gel were distributed Nationwide to retail stores via distributors. Lot numbers:

F200829088/F200829095/F200829107/D202728743/D202528742/D202428733/D202728743/
D2028753/D202528742/D202428733/ D202028689/ D201828660/D202428734/
E200128784/E200418795/D202428734/D202828689/D201828660/E201628912/E201628913/
E201628911/E201528902/E201528903/E201628910/E201628918/E201628914/E201628915/
E201628916/E201628917/ E202328969/E202428975/ E202528981 /E202128947/E201728918/
E201728919/E201428876/ E201828894/E201828920/E201428876/E201128850/E201328859/
E200628817/E200828826/E200928840/D202128699/D202428700.

Maquiladora Miniara S.A. de C.V. is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. Distributors that have Shine and Clean Hand Sanitizer which is being recalled, should stop using and distributing product and contact their clients.

Consumers who have questions about this recall can contact Maquiladora Miniara S.A. de C.V. By +52 55 33871987 + 52 55 8394 5857 the hours are available from 10:00 a.m. to 1:00 p.m. and from 2:00 p.m. to 4:00 p.m. Consumers should contact their doctor or healthcare provider if they have experienced any problems related to taking or using this medicine.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/maquiladora-miniara-sa-de-cv-issues-voluntary-nationwide-recall-shine-and-clean-hand-sanitizer-and

Source: FDA

#drugs #handsanitizer #unitedstates

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