D-1479-2016 Class III Terminated
FDA drug recall D-1479-2016 was initiated by Stason Pharmaceuticals, Inc. on August 23, 2016 and is designated Class III. 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. The recall status is terminated (terminated October 23, 2017). Affected quantity: 17,013 units.
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