Reported Mar 29, 2017 · Terminated
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only,…
Pfizer Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pfizer Inc · 100 North Route 206 · Peapack, NJ · 07977
Is this the product you have?
- Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only
- Distributed byNextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York
- NY 10017 Manufactured byTris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-30)
- Lot codes and dates
Lot #: 03216025AExp.01/18
- Amount recalled
- 9,666 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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