Drug & medication recalls

Rhodes Pharmaceuticals, L.P. recalls Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmace…

Recall date
April 17, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0710-2018
FDA classification
Class III
Brand / firm
Rhodes Pharmaceuticals, L.P.
Sold / distributed
Nationwide within the USA

Why it was recalled

Failed Dissolution Specification: Low dissolution outside of specifications

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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