← FDA ENFORCEMENT
D-0115-2025Class II

LNK International, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
LNK International, Inc.
Product type
Drug
Status
Terminated
Report date
2024-12-18
Distribution
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Firm state
NY
Product quantity
288 cases x 30 8,640 boxes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations: Released product should have been rejected.

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

Code / lot info

Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG

Other recalls SPEQ maps to Risk Management & CAPA
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Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →