D-0710-2018 Class III Terminated
FDA drug recall D-0710-2018 was initiated by Rhodes Pharmaceuticals, L.P. on April 17, 2018 and is designated Class III. Reason for recall: Failed Dissolution Specification: Low dissolution outside of specifications The recall status is terminated (terminated May 19, 2020). Affected quantity: 2454 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 9, 2018
- Initiation Date
- April 17, 2018
- Termination Date
- May 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2454 bottles
Product Description
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 for Recall
Failed Dissolution Specification: Low dissolution outside of specifications
Distribution Pattern
Nationwide within the USA
Code Information
Lot# AG8679B Exp. 01/2020