Recalls / Class II

Class IID-529-2014

Product

PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001

Affected lot / code info

PROPRANOLOL HCL Tablet, 10 mg has the following codes Pedigree: AD21790_34, EXP: 5/1/2014; Pedigree: AD52390_1, EXP: 5/17/2014; Pedigree: AD60272_37, EXP: 5/22/2014; Pedigree: W002732, EXP: 6/6/2014; Pedigree: W003229, EXP: 6/17/2014; Pedigree: AD60272_34, EXP: 5/22/2014; Pedigree: W003684, EXP: 6/25/2014; Pedigree: W002618, EXP: 6/4/2014; Pedigree: W003002, EXP: 6/11/2014; Pedigree: W003068, EXP: 6/12/2014; Pedigree: W003545, EXP: 6/21/2014.

Why it was recalled

Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD21790_31, EXP: 5/1/2014; buPROPion HCl ER (XL), Tablet, 150 mg, NDC 67767014130, Pedigree: AD52412_4, EXP: 4/30/2014; MULTIVITAMIN/MULTIMINERAL LOW IRON, Tablet, NDC 64376081601, Pedigree: AD60272_31, EXP: 5/22/2014; PERPHENAZINE, Tablet, 16 mg, NDC

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

2,299 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-529-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.