SYP Health Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
AA Products Inc. is recalling SYP Health Hand Sanitizer Alcohol Gel due to CGMP deviations and a history of subpotent ethanol and methanol contamination at the manufacturing facility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the manufacturing facility produced products found to contain methanol, a toxic substance that poses a significant risk of serious injury.
Plain-English summary
AA Products Inc. is recalling 1,392 bottles of SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL). The product is identified by the expiration date MAY/2021 and UPC 9 780201 378624. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations.
The recall is precautionary because the product was manufactured at the same facility that produced other products which the FDA sampled and found to be subpotent for ethanol and to contain methanol. Methanol is a toxic substance that can cause serious health issues if ingested or absorbed in significant quantities.
The affected product was distributed in Texas. Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return or dispose of it safely.
The recalled product
- Product
- SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .
- Manufacturer
- AA PRODUCTS INC
- Category
- Drug — Hand Sanitizer
- Affected units
- 1,392
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 (1)
- EXP MAY/2021
Distribution
Distributed in 1 state:
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