Drug Enforcement D-811-2014

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 60 mg, NDC 55513007430, Pedigree: W003742, EXP: 6/26/2014.

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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, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074707090.
Product quantity
90 Tablets
Reason for recall
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 60 mg, NDC 55513007430, Pedigree: W003742, EXP: 6/26/2014.
Recall initiation reason
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

Codes & Dates

Recall number
D-811-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
LEVOTHYROXINE SODIUM, Tablet, 175 mcg has the following codes: Pedigree: W003743, EXP: 6/26/2014.
More code info