Company Announcement
Raleigh, North Carolina, PNHC, LLC, d/b/a Heal the World, is voluntarily recalling all lots of Heal the World hand sanitizer packaged in 9.6 fl. oz containers to the consumer level. The products are being recalled because they resemble 9.6ounce water bottles. The recall does not affect any other Hand Sanitizer products from PNHC, LLC and/or Heal the World.
| Product | Size | NDC |
|---|---|---|
| Heal the World Hand Sanitizer | 9.6 FL. OZ (285 mL) | 73333-285-01 |
Lot Nos. SAA21, SAA24, SAA27, SAA22, SAA23, SAA29, SAA26, SAA28, SAA25, SAA32, SAA55, SAA56, SAA44, SAA60.
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, PNHC, LLC, d/b/a Heal the World has received no reports of adverse reactions and no complaints have been received.
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 9.6 ounce plastic bottles. The product can be identified by the bottle’s label pictured below. Product was distributed to selected retailers in the United States.
PNHC, LLC has provided notification to its distributors and retailers. Distributors and retailers that have product which is being recalled should stop distribution. While the product is not available for purchase and has not been available for several months, if a consumer has product which is being recalled he or she is advised to contact the entity who sold the product to consumer for return.
Consumers with questions regarding this recall can contact PNHC, LLC at 813-434-0741 from 9:00 am- 5:00 pm EST, Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to 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 External Link Disclaimer
- Regular Mail or Fax: Download form External Link Disclaimer 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.
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