Drug & medication recalls Moderate risk

SYP Health Hand Sanitizer Alcohol Gel 70% recalled over manufacturing violations

Recall date
September 24, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
AA PRODUCTS INC recalls SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacio…
Recall number
D-0102-2021
FDA classification
Class II
Brand / firm
AA PRODUCTS INC
Sold / distributed
Texas

Why it was recalled

CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 .

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