FDAFDA · Food and drugs·Recall number D-0840-2016
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
Published May 18, 2016 · Recall initiated: February 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications; three month stability time point.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Nationwide
- Lot
- Lot: 2005441, 01/2017, Code: 0378-3978-93
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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