Recalls / Class II
Class IID-1245-2022
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
- Affected lot / code info
- Lots: AA2012A, Exp. 07/04/2022
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Nephron Sterile Compounding Center LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, N/A, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 163 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-06-30
- FDA classified
- 2022-07-18
- Posted by FDA
- 2022-07-27
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1245-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.