FDA recall D-0607-2017

Product

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).

Reason for recall

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

Distribution

Nationwide within US

Key facts

Status

Terminated

Initiation date

2017-03-07

Report date

2017-03-29

Termination date

2019-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Peapack, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0607-2017