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Recall Observatory FDA recall evidence

Drug product

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.

D-1164-2017

August 04, 2017

Class III

Product summary

Firm
Pfizer Inc.
Event
Event 77862
Status
Terminated
Classification
Class III
Quantity
11,790 bottles
Official record key
drug-enforcement:D-1164-2017

Official wording

Reason: Failed Dissolution Specifications

Code information: Lot # 03216047A Exp. 02/18

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications