Drug Enforcement D-547-2014

Labeling: Label Mixup; MELATONIN Tablet, 1 mg may be potentially mislabeled as CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002692, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W003252, EXP: 6/17/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000391
Product quantity
200 Tablets
Reason for recall
Labeling: Label Mixup; MELATONIN Tablet, 1 mg may be potentially mislabeled as CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002692, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W003252, EXP: 6/17/2014.
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-547-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
MELATONIN Tablet, 1 mg has the following codes Pedigree: W002695, EXP: 6/5/2014; Pedigree: W003317, EXP: 6/18/2014.
More code info