Hand Sanitizer Recalled for Manufacturing Defects and Chemical Impurities
Superior Glove Works is recalling Synergy Hand Sanitizer due to acetaldehyde impurity and excess total impurities above specification limits. The 80% alcohol topical antiseptic was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a drug product with identified chemical impurities (acetaldehyde and excess total impurities) resulting from manufacturing defects. No illnesses or injuries have been reported. The classification reflects the potential risk posed by quality defects in a topical antiseptic, but without reported adverse health effects.
Plain-English summary
Superior Glove Works Ltd. is recalling Synergy Hand Sanitizer, an 80% alcohol topical antiseptic solution, due to manufacturing defects identified by the FDA. The recall affects 7,296 bottles of the 8.5 oz. (250 mL) product with lot number 200513TA and expiration date 05/2023.
The FDA's analysis found that the product contains acetaldehyde impurity and that the sum of all impurities exceed specification limits, indicating violations of current good manufacturing practices (CGMP). These chemical impurities in the hand sanitizer compromise product quality and safety.
The affected product was distributed nationwide in the United States.
The recalled product
- 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…
- Manufacturer
- SUPERIOR GLOVE WORKS, LTD.
- Category
- Drug — Topical Antiseptic
- Affected units
- 7,296
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 200513TA
- Exp. 05/2023.
Distribution
Distributed nationwide across the United States.
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