FDA recall D-0820-2021
Glenmark Pharmaceuticals Inc., USA · Class II · drug
Product
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2021-08-27
- Report date
- 2021-09-29
- Termination date
- 2023-10-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mahwah, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0820-2021