FDAFDA · Food and drugs·Recall number D-0357-2023
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.
Published March 8, 2023 · Recall initiated: February 22, 2023
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Distributor
- Nationwide in the USA
- Lot
- Lots: NB2017A, Exp. 03/04/2023; NB2019A, Exp. 02/21/2023; NB2024A, Exp. 03/27/2023; NB2025A, Exp. 03/24/2023; NB2027A, Exp. 04/07/2023; NB2035A, Exp. 05/22/20123; NB2038A, Exp. 06/02/2023; NB2045A, Exp. 06/25/2023; NB2053A, Exp. 07/29/2023; NB2058B, Exp. 08/16/2023; NB2064A, Exp. 09/07/2023; NB2069A, Exp. 09/25/2023; NB2071A, Exp. 10/01/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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