Drug Enforcement D-480-2014

Labeling: Label Mixup; ZINC SULFATE, Capsule, 50 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD30993_14, EXP: 5/9/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
ZINC SULFATE, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260
Product quantity
100 Capsules
Reason for recall
Labeling: Label Mixup; ZINC SULFATE, Capsule, 50 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD30993_14, EXP: 5/9/2014.
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-480-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
ZINC SULFATE, Capsule, 50 mg has the following code Pedigree: AD30994_8, EXP: 5/9/2014.
More code info