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

D-0150-2020

October 09, 2019

Class II

Product summary

Firm: Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Event: Event 83999
Status: Terminated
Classification: Class II
Quantity: 162 bags
Official record key: drug-enforcement:D-0150-2020

Reason: Lack of Assurance of Sterility; bags have potential to leak

Code information: Lots: AA9023A Exp. 10/24/2019; AA9023B Exp. 10/24/2019

Distribution pattern: Nationwide.

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility