Drug product
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.
D-0795-2021
Product summary
- Event
- Event 86266
- Status
- Terminated
- Classification
- Class I
- Quantity
- 22,680 bottles
- Official record key
drug-enforcement:D-0795-2021
Official wording
Reason: Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Code information: All lots including but not limited to: 200520673 and 200601685
Distribution pattern: Distributor in FL who further distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination