AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bot
Summary
The FDA issued a Class I for AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitam by American Screening LLC. Reason: Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles..
Details
Source
Drug Recall
External ID
D-0266-2022
Action Date
2021-12-15
Status
Completed
Category
drug
Product Description
AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2
Lot/Code Info: Black capped bottles have no lot numbers but include expiration dates of 5/21/2022 and 05/24/2022. Clear capped bottles have neither lot numbers nor expiration dates.
Quantity Affected: 153,336 bottles
Reason for Recall
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-19
Company
Shreveport, LA
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 28 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 (American Screening LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Screening LLC have FDA actions?
This is the only FDA action we have on record for American Screening LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0266-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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