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 I for Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8. by Grupo Asimex de Mexico SA de CV. Reason: Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content..
Details
Source
Drug Recall
External ID
D-0795-2021
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: 200520673 and 200601685
Quantity Affected: 22,680 bottles
Reason for Recall
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
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 I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-0795-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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