Recalls / Class III
Class IIID-1163-2017
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.
- Affected lot / code info
- Lot # 03216048A, Exp. 05/18
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 14,712 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-08-04
- FDA classified
- 2017-09-15
- Posted by FDA
- 2017-09-27
- Terminated
- 2019-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1163-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.