FDA recall D-0115-2025

LNK International, Inc. · Class II · drug

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

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.

Key facts

Status
Terminated
Initiation date
2024-11-14
Report date
2024-12-18
Termination date
2025-09-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0115-2025