LNK International, Inc.: Drug Recall

Recall #D-0115-2025 · 11/14/2024

Class II: Risk

Recall Details

Recall Number: D-0115-2025
Classification: Class II
Product Type: Drug
Recalling Firm: LNK International, Inc.
Status: Terminated
Date Initiated: 11/14/2024
Location: Hauppauge, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 288 cases x 30 8,640 boxes

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

Distribution Pattern

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

Other Recalls by LNK International, Inc.

Class III: Low Risk 10/11/2022

Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class III: Low Risk 08/04/2022

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Class III: Low Risk 07/07/2021

Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'

View all recalls by LNK International, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.