FDA Drug Recalls

Recalls / Class II

Class IID-0979-2022

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

Affected lot / code info
SKUs 2007625

Why it was recalled

cGMP deviations: product stored outside of labeled temperature requirements.

Recalling firm

Firm
Family Dollar Stores, Llc.
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
500 Volvo Pkwy, N/A, Chesapeake, Virginia 23320-1604

Distribution

Quantity
N/A
Distribution pattern
USA Nationwide

Timeline

Recall initiated
2022-05-17
FDA classified
2022-05-31
Posted by FDA
2022-06-08
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0979-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.