Drug Recall: 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 capl
LNK International, Inc. · November 14, 2024
Reason for Recall
CGMP Deviations: Released product should have been rejected.
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
Distribution
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
States Affected
NATIONWIDE
Quantity Affected
288 cases x 30 8,640 boxes
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0115-2025
Status: terminated
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.