FDA Drug Recalls

Recalls / Class II

Class IID-974-2014

Product

TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00591533501.

Affected lot / code info
TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg) has the following codes: Pedigree: AD73525_34, EXP: 5/30/2014.

Why it was recalled

Labeling: Label Mixup:TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg) may have potentially been mislabeled as the following drug: PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD73525_22, EXP: 5/30/2014.

Recalling firm

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

Distribution

Quantity
200 Tablets
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-974-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.