FDA Recall Terminated Historical recordClass III
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45
- Reason
- Failed Dissolution Specification: Low dissolution outside of specifications
- Published
- May 9, 2018
- Distribution
- Nationwide
