FDA recall D-1006-2014

Aidapak Services, LLC · Class II · drug

Product

TACROLIMUS, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210201.

Reason for recall

Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003168, EXP: 6/13/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: W003350, EXP: 6/18/2014.

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-1006-2014