August 2016 FDA Recall Drug by Stason Pharmaceuticals, Inc.
D-1479-2016 - Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.

This Class III drug recall was voluntarily initiated by Stason Pharmaceuticals, Inc. on August 23, 2016 for the product Drug. The FDA reported the reason for recall as 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 product was distributed in North Carolina and the recall is currently terminated.

Recall Number: D-1479-2016

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.
Initiated
08-23-2016
Reported
09-14-2016
Quantity
17,013 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75025
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Stason Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
North Carolina
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-23-2017
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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