Drug product
Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344
D-0022-2026
Product summary
- Event
- Event 97652
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11,386 tubes
- Official record key
drug-enforcement:D-0022-2026
Official wording
Reason: cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Code information: Lot#: 25196, Exp 2/16/2026
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations