Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when so
Summary
The FDA issued a Class II for Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can po by SUPERIOR GLOVE WORKS, LTD.. Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits..
Details
Source
Drug Recall
External ID
D-1537-2022
Action Date
2022-09-21
Status
Terminated
Category
drug
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/Code Info: Lot # 200513TA, Exp. 05/2023.
Quantity Affected: 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.
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-01
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 76 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUPERIOR GLOVE WORKS, LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUPERIOR GLOVE WORKS, LTD. have FDA actions?
This is the only FDA action we have on record for SUPERIOR GLOVE WORKS, LTD. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1537-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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