Drug 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
D-1479-2016
Product summary
- Event
- Event 75025
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,013 units
- Official record key
drug-enforcement:D-1479-2016
Official wording
Reason: Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
Code information: Lot #: 14F030, 14F031, 14F032, Exp. June 2017; 15G022, Exp. July 2018
Distribution pattern: North Carolina
Derived failure modes
-
Potency or specification failure
out of specification