Drug Enforcement D-565-2014

Labeling: Label Mixup; NIFEDIPINE Capsule, 10 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), NDC 64376081501, Pedigree: AD22609_7, EXP: 5/2/2014; NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_7, EXP: 9/23/2013.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
NIFEDIPINE Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386044024
Product quantity
202 Capsules
Reason for recall
Labeling: Label Mixup; NIFEDIPINE Capsule, 10 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), NDC 64376081501, Pedigree: AD22609_7, EXP: 5/2/2014; NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_7, EXP: 9/23/2013.
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-565-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
NIFEDIPINE, Capsule, 10 mg has the following codes Pedigree: AD23082_7, EXP: 9/23/2013; Pedigree: AD23082_10, EXP: 9/23/2013.
More code info