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

FDA recall notice · announced October 30, 2019 · Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide.
Lot/code information: Lots: AA9023A Exp. 10/24/2019; AA9023B Exp. 10/24/2019
Quantity: 162 bags
Status: Terminated
Products in this recall event:
- del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10 (D-0151-2020)
- 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 ND (D-0150-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.