LNK International product recalled over manufacturing violations

Recall date

November 14, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

LNK International, Inc. recalls Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorph…

Recall number

D-0115-2025

FDA classification

Class II

Brand / firm

LNK International, Inc.

Sold / distributed

Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.

Why it was recalled

CGMP Deviations: Released product should have been rejected.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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