Recalls / Class II

Class IID-920-2014

Product

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

Affected lot / code info

LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg) has the following codes: Pedigree: AD30140_40, EXP: 5/7/2014; Pedigree: AD46265_40, EXP: 5/15/2014; Pedigree: AD73525_49, EXP: 5/30/2014.

Why it was recalled

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:

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

600 Tablets

Distribution pattern

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Timeline

Recall initiated

2013-07-02

FDA classified

2014-01-20

Posted by FDA

2014-01-29

Terminated

2014-02-07

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-920-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.