FDAFDA · Food and drugs·Recall number D-1163-2017
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.
Published September 27, 2017 · Recall initiated: August 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pfizer Inc.
- Distributor
- Nationwide
- Lot
- Lot # 03216048A, Exp. 05/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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