Class III
Terminated
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.
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- January 14, 2016
- Posted
- March 2, 2016
- Recall Number
- D-0725-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9504 Bottles
- Firm Location
- Pennington, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Distribution
US Nationwide including Puerto Rico
Lot / Code Info
Lot #: MP4967, Expiry: 04/2016.
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