FDA recall D-598-2014

Aidapak Services, LLC · Class II · drug

Product

SOLIFENACIN SUCCINATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51248015001

Reason for recall

Labeling: Label Mixup; SOLIFENACIN SUCCINATE Tablet, 5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010601, Pedigree: W003754, EXP: 6/26/2014.

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-22
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-598-2014