- Company Announcement Date:
- June 21, 2021
- FDA Publish Date:
- June 22, 2021
- Product Type:
- Reason for Announcement:
Recall Reason Description
Packaged in containers resembling water bottles
- Company Name:
- Prairie Wolf Spirits, Inc.
- Brand Name:
Prairie Wolf Distillery
- Product Description:
Hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottles
Oklahoma City, Oklahoma, Prairie Wolf Spirits, Inc. is voluntarily recalling all lots of Prairie Wolf Distillery hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottles to the consumer level. The recall does not affect any other hand sanitizer products from Prairie Wolf Distillery. The product poses a risk of ingestion.
Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute. To date, Prairie Wolf Spirits has received no reports of adverse reactions related to this recall.
The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 16.9 ounce (UPC 6000331899) and 20 ounce plastic bottles (UPC 6000365984) that resemble water bottles. The product can be identified by the bottle’s labels pictured below. The product was distributed to selected customers and consumers nationwide in the United States.
Prairie Wolf Spirits is notifying its customers by mail and is arranging for return or replacement of all recalled products. The product was sold from a temporary retail location located at 111 E. Oklahoma Avenue, Guthrie, Oklahoma 73044. Additionally, it was available on the manufacturer’s website, but there were limited sales. Prairie Wolf Spirits also donated the products from its Guthrie warehouse. Consumers that have the product which is being recalled should stop using it and return it to the Prairie Wolf Spirits distillery, 124 E. Oklahoma Avenue, Guthrie, Oklahoma, or discard it.
Consumers with questions regarding this recall can contact Prairie Wolf Spirits by (405) 445-6448 or [email protected] on Monday through Friday from 9:00 a.m. and 5:00 p.m., CDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.