Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged in a) (16.9oz) 500 mL (UPC 8 6
Summary
The FDA issued a Class I for Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, by Prairie Wolf Spirits. Reason: Hand sanitizer packaged in bottles that resemble beverage containers..
Details
Source
Drug Recall
External ID
D-0694-2021
Action Date
2021-07-21
Status
Terminated
Category
drug
Product Description
Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged in a) (16.9oz) 500 mL (UPC 8 60003 31899 7, NDC: 73891-100-14); and b) (20oz) 591 mL (UPC 8 60003 65984 7 NDC: 73891-100-15) bottles, Prairie Wolf Distillery, Guthrie, Oklahoma
Lot/Code Info: All lots
Quantity Affected: Unknown
Reason for Recall
Hand sanitizer packaged in bottles that resemble beverage containers.
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-21
Company
Guthrie, OK
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 (Prairie Wolf Spirits) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Prairie Wolf Spirits have FDA actions?
This is the only FDA action we have on record for Prairie Wolf Spirits in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0694-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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