FDA Recall D-0979-2022
Family Dollar Stores, Llc. · Chesapeake, VA
Class II Ongoing 1458 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6
Reason for recall
cGMP deviations: product stored outside of labeled temperature requirements.
Recall record
- Recall number
D-0979-2022- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- USA Nationwide
- Recall initiated
- 2022-05-17
- Classified by FDA Center
- 2022-05-31
- FDA published
- 2022-06-08
- Recalling firm
- Family Dollar Stores, Llc.
- Firm location
- Chesapeake, VA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.