Why it was recalled
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.
Lot numbers, UPCs & expiration codes
Lot # 200513TA, Exp. 05/2023.
Where it was sold
Nationwide in the US.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1537-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 1, 2022
- FDA report date
- Sep 21, 2022
- Quantity
- 7,296 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUPERIOR GLOVE WORKS, LTD.
Original FDA data
Every field from FDA enforcement report D-1537-2022, exactly as published.
Show all FDA fields
- City
- Acton
- Status
- Terminated
- Country
- Canada
- Event ID
- 90827
- Address
- 36 Vimy St
- Code information
- Lot # 200513TA, Exp. 05/2023.
- Report date
- Sep 21, 2022
- Product type
- Drugs
- Recall number
- D-1537-2022
- Classification
- Class II
- Recalling firm
- SUPERIOR GLOVE WORKS, LTD.
- Product quantity
- 7,296 bottles
- Termination date
- Jun 27, 2023
- Reason for recall
- CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Sep 1, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2022