FDAClass IIJanuary 29, 2014

Oxybutynin Chloride recall: Labeling Error

OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521

Why was Oxybutynin Chloride recalled?

Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg) may have potentially been mislabeled as the following drug: PIMOZIDE, Tablet, 1 mg (1/2 of 2 mg), NDC 57844018701, Pedigree: AD73525_61, EXP: 5/30/2014.

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?

OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg) has the following codes: Pedigree: AD73525_64, EXP: 5/30/2014.

Product
OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521
Recalling firm
Aidapak Services, LLC
Quantity
199 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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