Drug product
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).
D-0607-2017
Product summary
- Firm
- Pfizer Inc
- Event
- Event 76663
- Status
- Terminated
- Classification
- Class III
- Quantity
- 28,938 units
- Official record key
drug-enforcement:D-0607-2017
Official wording
Reason: Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Code information: Lot #: 03215042A, Exp. 08/17.
Distribution pattern: Nationwide within US
Derived failure modes
-
Potency or specification failure
out of specification