Zydus Pharmaceuticals USA Inc recalls risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmeda
Recalled March 2, 2016 · FDA recall D-0725-2016 · Zydus Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: Out of specification for a known degradant. · FDA Class III
Units
9504 Bottles
Sold at
US Nationwide including Puerto Rico
Description
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Product
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.
Manufacturer(s)
Zydus Pharmaceuticals USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →