FDA-Drug2016-03-02Class III
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.
Zydus Pharmaceuticals USA Inc
Hazard
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Sold states
US Nationwide including Puerto Rico
Affected count
9504 Bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0725-2016Don't want to check this manually?
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