Recalls / Class II

Class IID-897-2014

Product

LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378180701.

Affected lot / code info

LEVOTHYROXINE SODIUM, Tablet, 88 mcg has the following codes: Pedigree: AD73652_10, EXP: 5/30/2014; Pedigree: W003047, EXP: 6/12/2014; Pedigree: W003476, EXP: 6/20/2014; Pedigree: W002967, EXP: 6/11/2014; Pedigree: AD42584_1, EXP: 5/14/2014.

Why it was recalled

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as one of the following drugs: NEBIVOLOL HCL, Tablet, 5 mg, NDC 00456140530, Pedigree: AD73611_7, EXP: 5/30/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: W003022, EXP: 6/12/2014; ISOSORBIDE DINITRATE, Tablet, 5 mg, NDC 00781163501, Pedigree: W003474, EXP: 6/20/2014; HYDROCORTISONE, Tabl

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-897-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.