FDA recall D-676-2014

Aidapak Services, LLC · Class II · drug

Product

CALCITRIOL Capsule, 0.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304024001

Reason for recall

Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, Tablet, 250 mg, NDC 10939043533, Pedigree: W003756, EXP: 5/31/2014; ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_28, EXP: 5/13/2014.

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-676-2014