Pfizer Inc. recalls Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted w…

Recall date

August 4, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1163-2017

FDA classification

Class III

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide

Why it was recalled

Failed Dissolution Specifications

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

What was recalled

Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-20.