FDA recall D-0591-2023
Astral SteriTech Private Ltd. · Class II · drug
Product
Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2023-05-15
- Report date
- 2023-05-24
- Termination date
- 2024-04-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Vadodara, N/A, India
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0591-2023