FDA recall D-0841-2016
Dr. Reddy's Laboratories, Inc. · Class II · drug
Product
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Reason for recall
Failed Impurities/Degradation Specifications; 12 month stability time point
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2016-03-30
- Report date
- 2016-05-18
- Termination date
- 2017-04-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Princeton, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0841-2016