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
Reported: December 18, 2024 Initiated: November 14, 2024 #D-0115-2025
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
Reason for Recall
CGMP Deviations: Released product should have been rejected.
Details
- Recalling Firm
- LNK International, Inc.
- Units Affected
- 288 cases x 30 8,640 boxes
- Distribution
- Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
- Location
- Hauppauge, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by LNK International, Inc.. Units affected: 288 cases x 30 8,640 boxes.
Why was this product recalled? ▼
CGMP Deviations: Released product should have been rejected.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2024. Severity: Moderate. Recall number: D-0115-2025.
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