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Drug Enforcement D-794-2014

Labeling: Label Mixup: CALCIUM ACETATE, Capsule, 667 mg may be potentially mislabeled as one of the following drugs: ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 64679071401, Pedigree: AD28355_1, EXP: 5/8/2014; acetaZOLAMIDE, Tablet, 250 mg, NDC 51672402301, Pedigree: AD62865_1, EXP: 5/23/2014; ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: W003028, EXP: 6/12/2014; PROPRANO

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description: CALCIUM ACETATE, Capsule, 667 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00054008826.
Product quantity: 3600 Capsules
Reason for recall: Labeling: Label Mixup: CALCIUM ACETATE, Capsule, 667 mg may be potentially mislabeled as one of the following drugs: ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 64679071401, Pedigree: AD28355_1, EXP: 5/8/2014; acetaZOLAMIDE, Tablet, 250 mg, NDC 51672402301, Pedigree: AD62865_1, EXP: 5/23/2014; ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: W003028, EXP: 6/12/2014; PROPRANO
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-794-2014
Event ID: 65690
Recall initiation date: July 2, 2013
Center classification date: January 20, 2014
Code info: CALCIUM ACETATE, Capsule, 667 mg has the following codes: Pedigree:AD30180_1, EXP: 5/8/2014; Pedigree:AD62865_4, EXP: 5/23/2014; Pedigree:W003045, EXP:6/12/2014; Pedigree: AD52412_11, EXP: 5/17/2014; Pedigree: AD54587_1, EXP: 5/21/2014; Pedigree: AD62986_1, EXP: 5/23/2014; Pedigree: AD73623_1, EXP: 5/30/2014; Pedigree: W003469, EXP: 6/20/2014; Pedigree: AD42592_1, EXP: 5/14/2014; Pedigree: AD52778_10, EXP: 5/20/2014; Pedigree: W003460, EXP: 6/20/2014; Pedigree: AD49463_1, EXP: 5/16/2014.
More code info: —