Recall record at a glance
| Official record | D-1537-2022 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | SUPERIOR GLOVE WORKS, LTD. |
| Report date | Sep 21, 2022 |
| Recall initiation date | Sep 1, 2022 |
| Quantity | 7,296 bottles |
| Location | Acton, Canada |
Official 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.
Why the product was recalled
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Distribution information
Nationwide in the US.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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