Class III
Terminated
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 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 24478-190-30).
This recall has been terminated (originally issued March 29, 2017).
- Company
- Pfizer Inc
- Recall Initiated
- March 7, 2017
- Posted
- March 29, 2017
- Recall Number
- D-0609-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,666 units
- Firm Location
- Peapack, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Distribution
Nationwide within US
Lot / Code Info
Lot #: 03216025A, Exp.01/18.
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