Selegiline Recalled

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.

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.