FDA recall D-864-2014

Aidapak Services, LLC · Class II · drug

Product

CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00143117101.

Reason for recall

Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg) may have potentially been mislabeled as the following drug:, LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD46312_1, EXP: 5/16/2014.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-29
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-864-2014