openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
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drug · product 1 of 1
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
Potency or specification failurereason.potency_specification_failure · v1.0.0
out of specification
These labels are deterministic app interpretations, not FDA categories.
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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.
Code information
Lot #: 14F030, 14F031, 14F032, Exp. June 2017; 15G022, Exp. July 2018
