PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 30, 2019 Initiated: October 9, 2019 #D-0150-2020

Product Description

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

Reason for Recall

Lack of Assurance of Sterility; bags have potential to leak

Details

Units Affected
162 bags
Distribution
Nationwide.
Location
West Columbia, SC

Frequently Asked Questions

What product was recalled?
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. Recalled by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center. Units affected: 162 bags.
Why was this product recalled?
Lack of Assurance of Sterility; bags have potential to leak
Which agency issued this recall?
This recall was issued by the FDA Drug on October 30, 2019. Severity: Moderate. Recall number: D-0150-2020.