FDA Recall D-0365-2021
PNHC, LLC. · Raleigh, NC
Class I — life-threatening Terminated 950 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL) bottle, Heal The World, LLC, Draper, UT 84020, UPC 6 19988 44038 0.
Reason for recall
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Recall record
- Recall number
D-0365-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- FL, CA
- Recall initiated
- 2021-03-10
- Classified by FDA Center
- 2021-04-30
- FDA published
- 2021-05-12
- Terminated
- 2023-10-16
- Recalling firm
- PNHC, LLC.
- Firm location
- Raleigh, NC