Recalls / Class II
Class IID-0150-2020
Product
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
- Affected lot / code info
- Lots: AA9023A Exp. 10/24/2019; AA9023B Exp. 10/24/2019
Why it was recalled
Lack of Assurance of Sterility; bags have potential to leak
Recalling firm
- Firm
- Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 162 bags
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2019-10-09
- FDA classified
- 2019-10-18
- Posted by FDA
- 2019-10-30
- Terminated
- 2020-12-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0150-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.