Drug Enforcement D-555-2014

Labeling: Label Mixup; LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially mislabeled as MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium), NDC 60258017201, Pedigree: AD30197_16, EXP: 5/9/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42192032901
Product quantity
102 Tablets
Reason for recall
Labeling: Label Mixup; LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially mislabeled as MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium), NDC 60258017201, Pedigree: AD30197_16, EXP: 5/9/2014.
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-555-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg has the following code Pedigree: AD30197_19, EXP: 3/31/2014.
More code info