FDA Drug Recalls

Recalls / Class II

Class IID-829-2014

Product

NORTRIPTYLINE HCL, Capsule, 75 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093081301.

Affected lot / code info
NORTRIPTYLINE HCL, Capsule, 75 mg has the following codes: Pedigree: AD21790_73, EXP: 5/1/2014; Pedigree: W003694, EXP: 6/26/2014.

Why it was recalled

Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 75 mg may have potentially been mislabeled as one of the following drugs: guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: AD21790_58, EXP: 5/1/2014; MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141509, Pedigree: W003693, EXP: 4/30/2014.

Recalling firm

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

Distribution

Quantity
100 Capsules
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Timeline

Recall initiated
2013-07-02
FDA classified
2014-01-20
Posted by FDA
2014-01-29
Terminated
2014-02-07
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-829-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.