Status
Terminated
Drug Enforcement D-1537-2022
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
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Classification
Class II
Report Date
September 21, 2022
Termination Date
June 27, 2023
Product Information
- 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.
- Product quantity
- 7,296 bottles
- Reason for recall
- CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US.
Location & Firm
- Recalling firm
- SUPERIOR GLOVE WORKS, LTD.
- Address
-
36 Vimy St
Canada - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1537-2022
- Event ID
- 90827
- Recall initiation date
- September 1, 2022
- Center classification date
- September 15, 2022
- Code info
- Lot # 200513TA, Exp. 05/2023.
- More code info
- —