Drug Enforcement D-574-2014

Labeling: Label Mixup; GALANTAMINE HBR ER, Capsule, 24 mg may be potentially mislabeled as ESCITALOPRAM, Tablet, 5 mg, NDC 00093585001, Pedigree: W003733, EXP: 6/26/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
GALANTAMINE HBR ER Capsule, 24 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335083783
Product quantity
30 Capsules
Reason for recall
Labeling: Label Mixup; GALANTAMINE HBR ER, Capsule, 24 mg may be potentially mislabeled as ESCITALOPRAM, Tablet, 5 mg, NDC 00093585001, Pedigree: W003733, EXP: 6/26/2014.
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-574-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
GALANTAMINE HBR ER, Capsule, 24 mg has the following code Pedigree: W003735, EXP: 5/31/2014.
More code info