CLASS II Drug recall · Reported 21 Sep 2022 · FDA Enforcement Report
Synergy Hand Sanitizer, Non-Sterile Solution to help reduce recalled
Superior Glove Works is recalling Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially, distributed nationwide in the US. The recall was initiated on 1 Sep 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1537-2022
- FDA event ID
- 90827
- Recalling firm
- Superior Glove Works, Acton
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Sep 2022
- FDA classified
- 15 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 1 Sep 2022 | Recall initiated by company | |
| 15 Sep 2022 | Classified by FDA | +14 days |
| 21 Sep 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US.
Questions about this recall
Why was it recalled?
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Which lots are affected?
Lot # 200513TA, Exp. 05/2023.
Where was it sold?
Nationwide in the US.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.