US Drug Recall Register
Class II · Moderate risk Terminated Initiated Oct 9, 2019 (7 years ago)

Amino Acid Injection 50 g/1000 mL

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility; bags have potential to leak

What 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

Recalling firm
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Origin
SC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0150-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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