Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 f
Summary
The FDA issued a Class II for Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8. by Grupo Asimex de Mexico SA de CV. Reason: CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain metha.
Details
Source
Drug Recall
External ID
D-0796-2021
Action Date
2021-09-22
Status
Terminated
Category
drug
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/Code Info: All lots including but not limited to a) 200520674 and b) 200525677
Quantity Affected: N/A
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.
Distribution
Distributor in FL who further distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2020-08-14
Company
Ciudad De Mexico, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Grupo Asimex de Mexico SA de CV has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Grupo Asimex de Mexico SA de CV) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Grupo Asimex de Mexico SA de CV have FDA actions?
Grupo Asimex de Mexico SA de CV has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0796-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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