Drug Enforcement D-842-2014

Labeling: Label Mixup: SIMVASTATIN, Tablet, 40 mg may have potentially been mislabeled as the following drug: METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304057901, Pedigree: AD21790_67, EXP: 5/1/2014.

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
SIMVASTATIN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093715598.
Product quantity
90 Tablets
Reason for recall
Labeling: Label Mixup: SIMVASTATIN, Tablet, 40 mg may have potentially been mislabeled as the following drug: METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304057901, Pedigree: AD21790_67, EXP: 5/1/2014.
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-842-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
SIMVASTATIN, Tablet, 40 mg has the following codes: Pedigree: AD22845_4, EXP: 5/2/2014.
More code info