Drug Enforcement D-920-2014

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:

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Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134101.
Product quantity
600 Tablets
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:
Recall initiation reason
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Initial firm notification
Telephone
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Location & Firm

Recalling firm
Aidapak Services, LLC
Address
14301 Se 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-920-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
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.
More code info
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