FDA recall D-0725-2016

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.

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for a known degradant.

Distribution

US Nationwide including Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-01-14

Report date

2016-03-02

Termination date

2020-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0725-2016