D-0796-2021 Class II Terminated
FDA drug recall D-0796-2021 was initiated by Grupo Asimex de Mexico SA de CV on August 14, 2020 and is designated Class II. Reason for recall: CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol. The recall status is terminated (terminated October 17, 2023). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- September 22, 2021
- Initiation Date
- August 14, 2020
- Termination Date
- October 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Reason for Recall
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 Pattern
Distributor in FL who further distributed Nationwide in the USA
Code Information
All lots including but not limited to a) 200520674 and b) 200525677