Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 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 24478-200-25.
Reported: September 27, 2017 Initiated: August 4, 2017 #D-1164-2017
Product Description
Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 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 24478-200-25.
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 11,790 bottles
- Distribution
- Nationwide
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 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 24478-200-25.. Recalled by Pfizer Inc.. Units affected: 11,790 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 27, 2017. Severity: Low. Recall number: D-1164-2017.
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