D-1163-2017 Class III Terminated
FDA drug recall D-1163-2017 was initiated by Pfizer Inc. on August 4, 2017 and is designated Class III. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated April 11, 2019). Affected quantity: 14,712 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 27, 2017
- Initiation Date
- August 4, 2017
- Termination Date
- April 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,712 bottles
Product Description
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.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide
Code Information
Lot # 03216048A, Exp. 05/18