The Recall Desk

FDA (Drugs) recall action 76663

Pfizer Inc recalled 3 products on 2017-03-29

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2017-03-29
Critical
0
Units
50,466

Why these products were recalled

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • LowFDA (Drugs)··2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling specific lots of Quillivant XR extended-release oral suspension because the product failed to meet dissolution specifications at 12 months.

    Product
    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…
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension due to failed dissolution specifications at 12 months.

    Product
    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…
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension because it failed to meet dissolution specifications at 12 months. The recall affects 28,938 units distributed nationwide.

    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…
    Category
    Distribution
    0 states