FDA Recall D-0795-2021
Grupo Asimex de Mexico SA de CV · Ciudad De Mexico, N/A
Class I — life-threatening Terminated 1159 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Reason for recall
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Recall record
- Recall number
D-0795-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Distributor in FL who further distributed Nationwide in the USA
- Recall initiated
- 2020-08-14
- Classified by FDA Center
- 2021-09-13
- FDA published
- 2021-09-22
- Terminated
- 2023-10-17
- Recalling firm
- Grupo Asimex de Mexico SA de CV
- Firm location
- Ciudad De Mexico, N/A, Mexico