Drug Enforcement D-939-2014

Labeling: Label Mixup: CALCIUM POLYCARBOPHIL, Tablet, 625 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 100 mg (1/2 of 200 mg), NDC 24385060173, Pedigree: ADWA00002146, EXP: 5/31/2014.

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
CALCIUM POLYCARBOPHIL, Tablet, 625 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536430611.
Product quantity
90 Tablets
Reason for recall
Labeling: Label Mixup: CALCIUM POLYCARBOPHIL, Tablet, 625 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 100 mg (1/2 of 200 mg), NDC 24385060173, Pedigree: ADWA00002146, EXP: 5/31/2014.
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-939-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
CALCIUM POLYCARBOPHIL, Tablet, 625 mg has the following codes: Pedigree: AD73592_11, EXP: 5/31/2014.
More code info