FDAFDA · Food and drugs·Recall number D-0607-2017
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).
Published March 29, 2017 · Recall initiated: March 7, 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: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pfizer Inc
- Distributor
- Nationwide within US
- Lot
- Lot #: 03215042A, Exp. 08/17.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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