Why it was recalled
CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
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.
Lot numbers, UPCs & expiration codes
All lots including but not limited to a) 200520674 and b) 200525677
Where it was sold
Distributor in FL who further distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0796-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 14, 2020
- FDA report date
- Sep 22, 2021
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Grupo Asimex de Mexico SA de CV
Original FDA data
Every field from FDA enforcement report D-0796-2021, exactly as published.
Show all FDA fields
- City
- Ciudad De Mexico
- Status
- Terminated
- Country
- Mexico
- Event ID
- 86266
- Address
- Mario Pani No 750 Piso 10-C
- Address (line 2)
- Col. Santa Fe Cuajimalpa, Cuajimalpa De Morelos
- Code information
- All lots including but not limited to a) 200520674 and b) 200525677
- Report date
- Sep 22, 2021
- Product type
- Drugs
- Recall number
- D-0796-2021
- Classification
- Class II
- Recalling firm
- Grupo Asimex de Mexico SA de CV
- Termination date
- Oct 17, 2023
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Distributor in FL who further distributed Nationwide in the USA
- Recall initiation date
- Aug 14, 2020
- Initial firm notification
- Telephone
- Center classification date
- Sep 13, 2021