FDA recall D-779-2014

Aidapak Services, LLC · Class II · drug

Product

SIROLIMUS, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008104105.

Reason for recall

Labeling: Label Mixup: SIROLIMUS, Tablet, 1 mg may be potentially mislabeled as one of the following drugs: PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_34, EXP: 5/22/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003325, 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-779-2014