D-0115-2025 Class II Terminated
FDA drug recall D-0115-2025 was initiated by LNK International, Inc. on Nov 14, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Released product should have been rejected. The recall status is terminated (terminated Sep 2, 2025). Affected quantity: 288 cases x 30 8,640 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 18, 2024
- Initiation Date
- Nov 14, 2024
- Termination Date
- Sep 2, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 288 cases x 30 8,640 boxes
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
Reason for Recall
CGMP Deviations: Released product should have been rejected.
Distribution Pattern
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Code Information
Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0115-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026