US Drug Recall Register
Class III · Low risk Terminated Initiated Mar 7, 2017 (9 years ago)

Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 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 24478-190-10).

Recalling firm
Pfizer Inc
NDC code
24478-190-10
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0607-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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