Drug & medication recalls Moderate risk

Florance Morris ANTISEPTIC Hand Sanitizer recalled over manufacturing violations

Recall date
August 14, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Grupo Asimex de Mexico SA de CV recalls Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81…
Recall number
D-0796-2021
FDA classification
Class II
Brand / firm
Grupo Asimex de Mexico SA de CV
Sold / distributed
Distributor in FL who further distributed Nationwide in the USA

Why it was recalled

CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain 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

Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.

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