FDA recall D-0594-2023
Astral SteriTech Private Ltd. · Class II · drug
Product
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75
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-0594-2023