FDA recall D-0261-2025
Aspen Biopharma Labs Pvt., Ltd. · Class II · drug
Product
Alprostadil Container Description: Amber color bottle
Reason for recall
CGMP Deviations
Distribution
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Key facts
- Status
- Ongoing
- Initiation date
- 2025-02-07
- Report date
- 2025-03-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Medchal Malkajgiri, India
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0261-2025