Pfizer Inc. recalls Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted wi
Recalled September 27, 2017 · FDA recall D-1163-2017 · Pfizer
Hazard
Failed Dissolution Specifications · FDA Class III
Units
14,712 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications
Product
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.
Manufacturer(s)
Pfizer Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →