D-0795-2021 Class I Terminated
FDA drug recall D-0795-2021 was initiated by Grupo Asimex de Mexico SA de CV on August 14, 2020 and is designated Class I. Reason for recall: Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content. The recall status is terminated (terminated October 17, 2023). Affected quantity: 22,680 bottles.
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
- 22,680 bottles
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
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Distribution Pattern
Distributor in FL who further distributed Nationwide in the USA
Code Information
All lots including but not limited to: 200520673 and 200601685