Recalls / Class I
Class ID-0780-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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. Made in Mexico UPC: 6 76753 00420 8,
- Affected lot / code info
- Lot No: E082020, "Best Buy": 5/21/2022
Why it was recalled
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Recalling firm
- Firm
- Global Sanitizers LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5979 S Valley View Blvd, N/A, Las Vegas, Nevada 89118-3111
Distribution
- Quantity
- 50,000 bottles
- Distribution pattern
- Product Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-05-12
- FDA classified
- 2021-08-30
- Posted by FDA
- 2021-09-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0780-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.