Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when... — FDA record D-1537-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
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.
Reason
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Classification
Class II
Recalling firm
SUPERIOR GLOVE WORKS, LTD.
Quantity
7,296 bottles
Agency-reported status
Terminated
Source record identifier
D-1537-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot # 200513TA, Exp. 05/2023.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the US.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Sep 21, 2022
Recall initiation date
Sep 1, 2022
Center classification date
Sep 15, 2022
Termination date
Jun 27, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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