Recalls / Class II

Class IID-551-2014

Product

VITAMIN B COMPLEX PROLONGED RELEASE Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022251

Affected lot / code info

VITAMIN B COMPLEX PROLONGED RELEASE Tablet has the following codes Pedigree: AD73627_26, EXP: 5/30/2014; Pedigree: AD76686_1, EXP: 5/31/2014.

Why it was recalled

Labeling: Label Mixup; VITAMIN B COMPLEX PROLONGED RELEASE Tablet may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD73627_23, EXP: 5/30/2014; TOLTERODINE TARTRATE ER, Capsule, 4 mg, NDC 00009519101, Pedigree: AD73686_1, EXP: 5/31/2014.

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

120 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-551-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.