FDA-Drug2019-10-30Class II
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
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Hazard
Lack of Assurance of Sterility; bags have potential to leak
Sold states
Nationwide.
Affected count
162 bags
Manufactured in
4500 12th Street Ext, West Columbia, SC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0150-2020Don't want to check this manually?
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