Drug & medication recalls

Stason Pharmaceuticals, Inc. recalls Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92…

Recall date
August 23, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1479-2016
FDA classification
Class III
Brand / firm
Stason Pharmaceuticals, Inc.
Sold / distributed
North Carolina

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.

Class III means the product violates regulations but is not likely to cause harm.

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

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