Zydus Pharmaceuticals USA Inc recalls risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmed…
- Recall date
- January 14, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0725-2016
- FDA classification
- Class III
- Brand / firm
- Zydus Pharmaceuticals USA Inc
- Sold / distributed
- US Nationwide including Puerto Rico
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
Get recall alerts
Free email alert whenever Zydus Pharmaceuticals USA Inc has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Zydus Pharmaceuticals USA Inc