Drug Enforcement D-980-2014

Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been mislabeled as the following drug: THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD70639_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: W003439, EXP: 6/20/2014; ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: W003641, EXP: 6/25/2014.

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00597000160.
Product quantity
300 Capsules
Reason for recall
Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been mislabeled as the following drug: THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD70639_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: W003439, EXP: 6/20/2014; ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: W003641, EXP: 6/25/2014.
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-980-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg has the following codes: Pedigree: AD70639_4, EXP: 7/28/2013; Pedigree: W003468, EXP: 8/19/2013; Pedigree: W003644, EXP: 8/24/2013.
More code info