FDA recall D-777-2014

Aidapak Services, LLC · Class II · drug

Product

CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00007337113.

Reason for recall

Labeling: Label Mixup: CARVEDILOL PHOSPHATE ER, Capsule, 20 mg may be potentially mislabeled as the following drug: BUMETANIDE, Tablet, 1 mg, NDC 00093423301, Pedigree: W003224, EXP: 6/17/2014.

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-777-2014