Drug product
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 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 69374-315-25.
D-0358-2023
Product summary
- Event
- Event 91749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 270,291 bottles
- Official record key
drug-enforcement:D-0358-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: NB2018A, Exp. 02/24/2023; NB2022A, Exp. 03/08/2023; NB2028A, Exp. 04/04/2023; NB2032A, Exp. 04/24/2023; NB2036A, Exp. 05/24/2023; NB2043A, Exp. 06/17/2023; NB2046A, Exp. 06/26/2023; NB2049A, Exp. 07/21/2023; NB2052A, Exp. 07/27/2023; NB2062A, Exp. 09/13/2023; NB2068A, Exp. 09/23/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility