Home / Recalls / Rhodes Pharmaceuticals, L.P. / D-0710-2018

D-0710-2018 Class III Terminated

Recalled by Rhodes Pharmaceuticals, L.P. — Coventry, RI

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