FDA recall D-1171-2023
Aurobindo Pharma USA Inc. · Class II · drug
Product
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Reason for recall
Failed dissolution specifications - results obtained were below spec average.
Distribution
USA nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2023-08-02
- Report date
- 2023-09-27
- Termination date
- 2024-08-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- East Windsor, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1171-2023