FDAFDA · Food and drugs·Recall number D-0115-2025
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
Published December 18, 2024 · Recall initiated: November 14, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Released product should have been rejected.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SEVERE COLD AND FLU PLUS CONGESTION
- Manufacturer
- LNK International, Inc.
- Distributor
- Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
- UPC
- 0196633991997
- Lot
- Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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