FDAClass IIJanuary 29, 2014

Calcium Acetate recall: Labeling Error

CALCIUM ACETATE, Capsule, 667 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00054008826.

Why was Calcium Acetate recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
CALCIUM ACETATE, Capsule, 667 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00054008826.
Recalling firm
Aidapak Services, LLC
Quantity
3600 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls