Class III · Low risk
Mercaptopurine Tablets
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Selegiline HCL Tablets USP 5mg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
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
Affected NDC
51862-0146-06
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Stason Pharmaceuticals, Inc.
- NDC code
- 51862-146-06
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1479-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Stason Pharmaceuticals, Inc.
All 2016 recallsOther dissolution failure recalls from 2016
All dissolution failure recalls
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
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