FDA Drug Recalls

Recalls / Class II

Class IID-630-2014

Product

CITALOPRAM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050788

Affected lot / code info
CITALOPRAM, Tablet, 10 mg has the following codes Pedigree: AD56921_1, EXP: 5/21/2014; Pedigree: W002844, EXP: 6/7/2014.

Why it was recalled

Labeling:Label Mixup; CITALOPRAM Tablet, 10 mg may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 5 mg, NDC 00603497521, Pedigree: AD52778_61, EXP: 5/20/2014; COENZYME Q-10, Capsule, 30 mg, NDC 00904501546, Pedigree: W002814, EXP: 6/7/2014.

Recalling firm

Firm
Aidapak Services, LLC
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity
299 Tablets
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Timeline

Recall initiated
2013-07-02
FDA classified
2014-01-16
Posted by FDA
2014-01-22
Terminated
2014-02-07
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-630-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.