FDAFDA · Food and drugs·Recall number D-0725-2016
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
Published March 2, 2016 · Recall initiated: January 14, 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 Impurities/Degradation Specifications: Out of specification for a known degradant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Distributor
- US Nationwide including Puerto Rico
- Lot
- Lot #: MP4967, Expiry: 04/2016.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States