FDA recall D-1245-2022
Nephron Sterile Compounding Center LLC · Class II · drug
Product
Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA
Key facts
- Status
- Terminated
- Initiation date
- 2022-06-30
- Report date
- 2022-07-27
- Termination date
- 2024-06-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- West Columbia, SC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1245-2022