Recalls / Class III
Class IIID-0607-2017
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).
- Affected lot / code info
- Lot #: 03215042A, Exp. 08/17.
Why it was recalled
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Recalling firm
- Firm
- Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 North Route 206, Peapack, New Jersey 07977
Distribution
- Quantity
- 28,938 units
- Distribution pattern
- Nationwide within US
Timeline
- Recall initiated
- 2017-03-07
- FDA classified
- 2017-03-22
- Posted by FDA
- 2017-03-29
- Terminated
- 2019-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0607-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.