November 2024 FDA Recall Severe Cold And Flu Plus Congestion by Lnk International, Inc.
D-0115-2025 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Lnk International, Inc. on November 14, 2024 for the product Severe Cold And Flu Plus Congestion. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0115-2025

Reason for Recall
CGMP Deviations: Released product should have been rejected.
Initiated
11-14-2024
Reported
12-18-2024
Quantity
288 cases x 30 8,640 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95773
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
LNK International, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-02-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

63981-795-81 Severe Cold And Flu Plus Congestion