FDAClass IIJanuary 29, 2014

Imipramine HCL recall: Labeling Error

IMIPRAMINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781176401.

Why was Imipramine HCL recalled?

Labeling: Label Mixup: IMIPRAMINE HCL, Tablet, 25 mg may have potentially been mislabeled as the following drug: FENOFIBRATE, Tablet, 54 mg, NDC 00115551110, Pedigree: AD49448_7, EXP: 5/17/2014.

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?

IMIPRAMINE HCL, Tablet, 25 mg has the following codes: Pedigree: AD49448_10, EXP: 5/17/2014.

Product
IMIPRAMINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781176401.
Recalling firm
Aidapak Services, LLC
Quantity
100 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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