Drug product
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81
D-0115-2025
Product summary
- Event
- Event 95773
- Status
- Terminated
- Classification
- Class II
- Quantity
- 288 cases x 30 8,640 boxes
- Official record key
drug-enforcement:D-0115-2025
Official wording
Reason: CGMP Deviations: Released product should have been rejected.
Code information: Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
Distribution pattern: Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations