Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial
Summary
The FDA issued a Class I for Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in by Ardil Comercial S.R.L.. Reason: Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles..
Details
Source
Drug Recall
External ID
D-0691-2021
Action Date
2021-07-21
Status
Ongoing
Category
drug
Product Description
Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Domingo, Dominican Republic UPC 7 487040 301587
Lot/Code Info: Batch Number # 079932-4611-05-J, exp. date May 2022
Quantity Affected: 1,260 bottles
Reason for Recall
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Distribution
Product was distributed to one client in NYC who further distributed the product.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-22
Company
Santo Domingo Este
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 22 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Ardil Comercial S.R.L.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ardil Comercial S.R.L. have FDA actions?
This is the only FDA action we have on record for Ardil Comercial S.R.L. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0691-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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