DRUG RECALL

Selegiline Recalled

September 14, 2016

The US Food and Drug Administration (FDA) announced the recall of selegiline hydrochloride tablets, USP, 5mg (NDC 51862-146-06).

What prompted the Class III recalls? An “out of specification result for dissolution of stability samples” prompted the recall, according to the FDA’s Enforcement Report.

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The lots below are being recalled.

Lot

Expiration

14F030

June 2017

14F031

June 2017

14F032

June 2017

15G022

July 2018

 

The products were manufactured by Stason Pharmaceuticals, Inc. and distributed by Libertas Pharma, Inc.

Other medications used to treat Parkinson’s disease have been recalled. In one instance the discovery of the wrong pill prompted a recall. In another, the presence of an unknown impurity was discovered.

 

--Stephanie Vaccaro

 

Reference:

US Food and Drug Administration. FDA Enforcement Report – Week of September 14, 2016. www.fda.gov. Accessed September 14, 2016.