Severe Cold And Flu Plus Congestion Kit
FDA Recall NDC 63981-795
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Severe Cold And Flu Plus Congestion (NDC 63981-795). A significant event, classified as Class II, was initiated on Nov 14, 2024 by Costco Wholesale Corporation. The reported reason for this action was: "CGMP Deviations: Released product should have been rejected."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Released product should have been rejected.
Nov 14, 2024
Dec 18, 2024
288 cases x 30 8,640 boxes
Recall Profile & Regulatory Data
Event ID
95773
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
LNK International, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Termination Date
Sep 02, 2025
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
Batch or Lot Expiration Information
Lot# P139953, exp. date 2026/AUG
Lot# P139815, exp. date 2026/AUG
Affected Packages Involved in this Recall
63981-795-81Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
