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-0796-2021
Product summary
- Event
- Event 86266
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0796-2021
Official wording
Reason: CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Code information: All lots including but not limited to a) 200520674 and b) 200525677
Distribution pattern: Distributor in FL who further distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
found to contain methanol
-
Manufacturing or process control
CGMP Deviations