Status
Terminated
Drug Enforcement D-0115-2025
CGMP Deviations: Released product should have been rejected.
Classification
Class II
Report Date
December 18, 2024
Termination Date
September 2, 2025
Product Information
- Product description
- 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
- Product quantity
- 288 cases x 30 8,640 boxes
- Reason for recall
- CGMP Deviations: Released product should have been rejected.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Location & Firm
- Recalling firm
- LNK International, Inc.
- Address
-
22 Arkay Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0115-2025
- Event ID
- 95773
- Recall initiation date
- November 14, 2024
- Center classification date
- December 9, 2024
- Code info
- Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
- More code info
- —