FDA recall D-920-2014

Aidapak Services, LLC · Class II · drug

Product

LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134101.

Reason for recall

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg) may have potentially been mislabeled as one of the following drugs: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD30180_1, EXP: 5/8/2014; carBAMazepine ER, Capsule, 200 mg, NDC 66993040832, Pedigree: AD32764_14, EXP: 5/14/2014; CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 00378022201, Pedigree:

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-920-2014