Pfizer Inc recalls Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed
Recalled March 29, 2017 · FDA recall D-0608-2017 · Pfizer
Hazard
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. · FDA Class III
Units
11,862 units
Sold at
Nationwide within US
Description
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Product
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 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 24478-205-25).
Manufacturer(s)
Pfizer Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →