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

FDA recall notice · announced May 9, 2018 · Rhodes Pharmaceuticals, L.p

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Failed Dissolution Specification: Low dissolution outside of specifications

Notes

Distribution: Nationwide within the USA
Lot/code information: Lot# AG8679B Exp. 01/2020
Quantity: 2454 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0710-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.