FDA recall record

Grupo Asimex de Mexico SA de CV Florance Morris ANTISEPTIC Hand Sanitizer recall — FDA D-0796-2021

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 IIclassification
D-0796-2021official record ID
Sep 22, 2021report date

Recall record at a glance

Official recordD-0796-2021
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmGrupo Asimex de Mexico SA de CV
Report dateSep 22, 2021
Recall initiation dateAug 14, 2020
QuantityN/A
LocationCiudad De Mexico, N/A, Mexico

Official product description

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.

Why the product 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.

Distribution information

Distributor in FL who further distributed Nationwide in the USA

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Telephone.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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