FDA recall D-0150-2020

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center · Class II · drug

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

Reason for recall

Lack of Assurance of Sterility; bags have potential to leak

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2019-10-09
Report date: 2019-10-30
Termination date: 2020-12-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0150-2020