Recalls / Class II
Class IID-0357-2023
Product
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.
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Nephron Sterile Compounding Center LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, N/A, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 305,895 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-02-22
- FDA classified
- 2023-02-27
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0357-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.