Drug 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.
D-1163-2017
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 77862
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,712 bottles
- Official record key
drug-enforcement:D-1163-2017
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # 03216048A, Exp. 05/18
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications