Drug Enforcement D-952-2014

Labeling: Label Mixup: ESTRADIOL, Tablet, 0.5 mg may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, GUM, 2 mg, NDC 00536302923, Pedigree: AD33897_28, EXP: 2/28/2014.

2 Views

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
ESTRADIOL, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555089902.
Product quantity
100 Tablets
Reason for recall
Labeling: Label Mixup: ESTRADIOL, Tablet, 0.5 mg may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, GUM, 2 mg, NDC 00536302923, Pedigree: AD33897_28, EXP: 2/28/2014.
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-952-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
ESTRADIOL, Tablet, 0.5 mg has the following codes: Pedigree: AD30993_11, EXP: 5/9/2014.
More code info