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Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen...

FDA Recall #D-0115-2025 — Class II — November 14, 2024

Recall #D-0115-2025 Date: November 14, 2024 Classification: Class II Status: Terminated

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.

Recalling Firm

LNK International, Inc. — Hauppauge, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

288 cases x 30 8,640 boxes

Distribution

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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