Drug Enforcement D-496-2014

Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 50 mg, NDC 00093081201, Pedigree: AD21790_70, EXP: 5/1/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 05445800022
Product quantity
90 Capsules
Reason for recall
Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 50 mg, NDC 00093081201, Pedigree: AD21790_70, 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-496-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
OMEGA-3 FATTY ACID, Capsule, 1000 mg has the following code Pedigree: AD21858_4, EXP: 5/1/2014.
More code info