SUPERIOR GLOVE WORKS, LTD.: Drug Recall
Recall #D-1537-2022 · 09/01/2022
Class II: Risk
Recall Details
- Recall Number
- D-1537-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- SUPERIOR GLOVE WORKS, LTD.
- Status
- Terminated
- Date Initiated
- 09/01/2022
- Location
- Acton, Canada
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
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.
Distribution Pattern
Nationwide in the US.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.