Pfizer Inc recalls Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distribute…

Recall date

March 7, 2017

Source

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

Recall number

D-0609-2017

FDA classification

Class III

Brand / firm

Pfizer Inc

Sold / distributed

Nationwide within US

Why it was recalled

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

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, 900 mg/180 mL (25mg/5mL), 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 24478-190-30).