Recalls / Class III
Class IIID-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.
- Affected lot / code info
- Lot #: MP4967, Expiry: 04/2016.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 9504 Bottles
- Distribution pattern
- US Nationwide including Puerto Rico
Timeline
- Recall initiated
- 2016-01-14
- FDA classified
- 2016-02-22
- Posted by FDA
- 2016-03-02
- Terminated
- 2020-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0725-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.