Recalls / Class II

Class IID-1009-2014

Product

LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781518392.

Affected lot / code info

LEVOTHYROXINE SODIUM, Tablet, 88 mcg has the following codes: Pedigree: AD46265_34, EXP: 5/15/2014; Pedigree: AD70629_13, EXP: 5/29/2014; Pedigree: W003439, EXP: 6/20/2014; Pedigree: AD60272_73, EXP: 5/22/2014.

Why it was recalled

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as one of the following drugs: clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD46265_1, EXP: 5/15/2014; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg, NDC 63304029601, Pedigree: AD70629_10, EXP: 5/29/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 76439030910, Pedigree: W003438, EXP:

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

360 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-1009-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.