Drug product
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
D-0263-2026
Product summary
- Event
- Event 98239
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0263-2026
Official wording
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Code information: All lots within expiry distributed by Gold Star Distribution.
Distribution pattern: US Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations