Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorpha
Summary
The FDA issued a Class II for Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pac by LNK International, Inc.. Reason: CGMP Deviations: Released product should have been rejected..
Details
Source
Drug Recall
External ID
D-0115-2025
Action Date
2024-12-18
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
Quantity Affected: 288 cases x 30 8,640 boxes
Reason for Recall
CGMP Deviations: Released product should have been rejected.
Distribution
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-14
Company
Hauppauge, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 105 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
LNK International, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LNK International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LNK International, Inc. have FDA actions?
LNK International, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0115-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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