FDAFDA · Food and drugs·Recall number D-1479-2016
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
Published September 14, 2016 · Recall initiated: August 23, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stason Pharmaceuticals, Inc.
- Distributor
- North Carolina
- Lot
- Lot #: 14F030, 14F031, 14F032, Exp. June 2017; 15G022, Exp. July 2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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