Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 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 24478-205-25).
Reported: March 29, 2017 Initiated: March 7, 2017 #D-0608-2017
Product Description
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 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 24478-205-25).
Reason for Recall
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Details
- Recalling Firm
- Pfizer Inc
- Units Affected
- 11,862 units
- Distribution
- Nationwide within US
- Location
- Peapack, NJ
Frequently Asked Questions
What product was recalled? ▼
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 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 24478-205-25).. Recalled by Pfizer Inc. Units affected: 11,862 units.
Why was this product recalled? ▼
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 29, 2017. Severity: Low. Recall number: D-0608-2017.
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