Drug Enforcement D-941-2014

Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 15 Billion Cells, NDC 49100036374, Pedigree: W003787, EXP: 6/27/2014; LEVOTHYROXINE/ LIOTHYRONINE, Tablet, 19 mcg/4.5 mcg, NDC 42192032901, Pedigree: AD30197_19, EXP: 3/31/2014; CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, NDC 00

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Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536440801.
Product quantity
695 Tablets
Reason for recall
Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 15 Billion Cells, NDC 49100036374, Pedigree: W003787, EXP: 6/27/2014; LEVOTHYROXINE/ LIOTHYRONINE, Tablet, 19 mcg/4.5 mcg, NDC 42192032901, Pedigree: AD30197_19, EXP: 3/31/2014; CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, NDC 00
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-941-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
PYRIDOXINE HCL, Tablet, 50 mg has the following codes: Pedigree: W003824, EXP: 6/27/2014; Pedigree: AD30197_22, EXP: 5/9/2014; Pedigree: AD60428_10, EXP: 5/22/2014.
More code info
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