US Drug Recall Register
Class III · Low risk Terminated Initiated Aug 23, 2016 (10 years ago)

Selegiline HCL Tablets USP 5mg

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was 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 was recalled

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.
NDC code
51862-146-06
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1479-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.