Drug & medication recalls Moderate risk

Protz real protection Antibacterial Hand Sanitizer recalled over manufacturing violations

Recall date
August 25, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Asiaticon, SA de CV recalls Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med…
Recall number
D-0117-2021
FDA classification
Class II
Brand / firm
Asiaticon, SA de CV
Sold / distributed
Distributed in Texas

Why it was recalled

Lack of CGMPs:

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

What was recalled

Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019 005002

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