FDAHealthNovember 14, 2024
LNK International, Inc. — Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 m
⚠️ CGMP Deviations: Released product should have been rejected.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 14, 2024
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
What's affected?
- 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
- UPC
- 0196633991997
- Lot code
- P139953
Additional details
Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 288 cases x 30 8,640 boxes.
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