Drug product
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
D-0710-2018
Product summary
- Event
- Event 79820
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2454 bottles
- Official record key
drug-enforcement:D-0710-2018
Official wording
Reason: Failed Dissolution Specification: Low dissolution outside of specifications
Code information: Lot# AG8679B Exp. 01/2020
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification