MEDICALLY MINDED Hand Sanitizer Gel Recalled for Manufacturing Deviations
Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (70% ethyl alcohol, 8 fl oz bottles) distributed nationwide due to manufacturing deviations under conditions that produced a methanol-contaminated product lot.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a contamination hazard (methanol) in a product applied topically to skin. Methanol is a known toxic substance. Although no illnesses are reported in the source text, the confirmed presence of methanol in a related product lot and the widespread distribution nationwide warrant a Severe classification under the rubric's criteria for drug recalls involving significant health risks.
Plain-English summary
Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (70% v/v ethyl alcohol) in 8 fluid ounce bottles due to Current Good Manufacturing Practice (CGMP) deviations.
The product was manufactured under the same conditions as a product lot found to contain methanol, a toxic substance. The affected lots are E332020 and E212020, with a stated "Best Buy" date of 5/21/2022.
The product has been distributed nationwide in the USA. Consumers who have purchased this hand sanitizer should discontinue use and consult appropriate health or product safety resources for guidance on disposal and potential health effects from exposure.
The recalled product
- Product
- MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200. Distributed by SBL Brands, LLC Las Vegas, NV 89119 UPC: 6…
- Manufacturer
- Global Sanitizers LLC
- Category
- Drug — Hand Sanitizer
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot No: E332020
- E212020 "Best Buy": 5/21/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Global Sanitizers LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Global Sanitizers LLC
See all →- SevereMEDICALLY MINDED Hand Sanitizer Gel Recalled for Methanol Contamination
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- SevereMEDICALLY MINDED Hand Sanitizer Gel recalled for methanol contamination
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