Drug product
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00417 8
D-0778-2021
Product summary
- Event
- Event 87941
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50,000 bottles
- Official record key
drug-enforcement:D-0778-2021
Official wording
Reason: CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Code information: Lot No: GV4420205 Best By, 5/21/2022
Distribution pattern: Product Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
found to contain methanol
-
Manufacturing or process control
CGMP Deviations