Drug product
TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT
D-0277-2026
Product summary
- Event
- Event 98239
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0277-2026
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