FDAClass IIJanuary 22, 2014

Diltiazem HCL ER Capsule recall: Labeling Error

DILTIAZEM HCL ER Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884083109

Why was Diltiazem HCL ER Capsule recalled?

Labeling: Label Mixup; DILTIAZEM HCL ER Capsule, 240 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD52433_4, EXP: 5/17/2014; PARoxetine HCl, Tablet, 10 mg, NDC 13107015430, Pedigree: AD52778_67, EXP: 5/20/2014.

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?

DILTIAZEM HCL ER, Capsule, 240 mg has the following codes Pedigree: AD52375_1, EXP: 5/17/2014; Pedigree: AD56917_1, EXP: 5/21/2014.

Product
DILTIAZEM HCL ER Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884083109
Recalling firm
Aidapak Services, LLC
Quantity
180 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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