PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: September 14, 2016 Initiated: August 23, 2016 #D-1479-2016

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.

Details

Units Affected
17,013 units
Distribution
North Carolina
Location
Irvine, CA

Frequently Asked Questions

What product 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. Recalled by Stason Pharmaceuticals, Inc.. Units affected: 17,013 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 14, 2016. Severity: Low. Recall number: D-1479-2016.