Drug Enforcement D-546-2014

Labeling: Label Mixup; MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg) may be potentially mislabeled as FLUVASTATIN, Capsule, 20 mg, NDC 00378802077, Pedigree: W002655, EXP: 6/4/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000322
Product quantity
90 Tablets
Reason for recall
Labeling: Label Mixup; MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg) may be potentially mislabeled as FLUVASTATIN, Capsule, 20 mg, NDC 00378802077, Pedigree: W002655, EXP: 6/4/2014.
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-546-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg) has the following code Pedigree: W002687, EXP: 6/5/2014.
More code info