The Recall Desk
LowFDA (Drugs)·D-1479-2016·Announced 2016-09-14

Stason Recalls Selegiline HCl Tablets Due to Dissolution Failure

Stason Pharmaceuticals is recalling Selegiline HCl tablets 5mg due to out-of-specification dissolution results for stability samples.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg, 60-count bottles. The recall was initiated because stability samples produced an out-of-specification result for dissolution.

The affected product is prescription-only and was distributed in North Carolina. The specific lots involved are 14F030, 14F031, and 14F032 with an expiration date of June 2017, and lot 15G022 with an expiration date of July 2018. The NDC number for the product is 51862-146-06.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for guidance on replacement or disposal.

The recalled product

Product
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
Manufacturer
Stason Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
17,013

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot #: 14F030
  • 14F031
  • 14F032
  • Exp. June 2017
  • 15G022
  • Exp. July 2018

Distribution

Distributed in 1 state:

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