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Recall Observatory FDA recall evidence

Drug product

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.

D-0356-2023

February 22, 2023

Class II

Product summary

Firm
Nephron Sterile Compounding Center LLC
Event
Event 91749
Status
Terminated
Classification
Class II
Quantity
443,483 bottles
Official record key
drug-enforcement:D-0356-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: NB2015A, Exp. 02/27/2023; NB2016A, Exp. 02/19/2023; NB2021A, Exp. 03/05/2023; NB2023A, Exp. 03/12/2023; NB2026A, Exp. 03/29/2023; NB2029A, Exp. 04/21/2023; NB2031A, Exp. 04/21/2023; NB2033A, Exp. 05/10/2023; NB2034A, Exp. 05/19/2023; NB2037A, Exp. 05/25/2023; NB2039A, Exp. 06/05/2023; NB2041A, Exp. 06/14/2023; NB2044A, Exp. 06/18/2023; NB2050A, Exp. 07/19/2023; NB2054A, Exp. 08/04/2023; NB2057A, Exp. 08/12/2023; NB2059A, Exp. 08/20/2023; NB2061A, Exp. 09/14/2023; NB2067A, Exp. 09/22/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility