FDAFDA · Food and drugs·Recall number D-0150-2020
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 NDC: 69374-988-10
Published October 30, 2019 · Recall initiated: October 9, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; bags have potential to leak
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Distributor
- Nationwide.
- Lot
- Lots: AA9023A Exp. 10/24/2019; AA9023B Exp. 10/24/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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