D-1537-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 21, 2022
- Initiation Date
- September 1, 2022
- Termination Date
- June 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,296 bottles
Product Description
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.
Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Distribution Pattern
Nationwide in the US.
Code Information
Lot # 200513TA, Exp. 05/2023.