D-0607-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 29, 2017
- Initiation Date
- March 7, 2017
- Termination Date
- May 31, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,938 units
Product Description
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 Pattern
Nationwide within US
Code Information
Lot #: 03215042A, Exp. 08/17.