Drug product
Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96536 9
D-0980-2022
Product summary
- Event
- Event 90270
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0980-2022
Official wording
Reason: cGMP deviations: product stored outside of labeled temperature requirements.
Code information: SKUs 2007626
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations