FDAClass IIISeptember 14, 2016

Selegiline HCL Tablets USP 5mg recall: Failed Dissolution

Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06

Why was Selegiline HCL Tablets USP 5mg recalled?

Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.

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?

Lot #: 14F030, 14F031, 14F032, Exp. June 2017; 15G022, Exp. July 2018

Product
Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
Recalling firm
Stason Pharmaceuticals, Inc.
Quantity
17,013 units
Distribution
North Carolina
Recall date
September 14, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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