Home / Recalls / Stason Pharmaceuticals, Inc. / D-1479-2016

D-1479-2016 Class III Terminated

Recalled by Stason Pharmaceuticals, Inc. — Irvine, CA

Recall Details

Product Type: Drugs
Report Date: September 14, 2016
Initiation Date: August 23, 2016
Termination Date: October 23, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17,013 units

Product Description

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

Reason for Recall

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

Distribution Pattern

North Carolina

Code Information

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