FDA recall D-0710-2018

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

Distribution

Nationwide within the USA

Key facts

Status

Terminated

Initiation date

2018-04-17

Report date

2018-05-09

Termination date

2020-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Coventry, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0710-2018