Drug product
Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy Street, Acton, Ontario, L7J 1S1, Canada, Made in Canada, UPC: 779406201594.
D-1537-2022
Product summary
- Event
- Event 90827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,296 bottles
- Official record key
drug-enforcement:D-1537-2022
Official wording
Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Code information: Lot # 200513TA, Exp. 05/2023.
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations