Drug product
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, Made in China, ALSO distributed with Custom front labels as follows a) Sadie G. Mays Health & Rehabilitation Center, b) Pacers logo, c) northwood CHURCH, d) ROGERTHEROOFER.com and e) SoFi Stadium Wash-Free Hand Sanitizer. UPC 8 19845 00597 8
D-0239-2021
Product summary
- Event
- Event 87037
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36,505 bottles
- Official record key
drug-enforcement:D-0239-2021
Official wording
Reason: CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Code information: Lot 2020/05/11, exp 2023/05/10
Distribution pattern: Nationwide USA and Canada
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
subpotent