Product Safety Recalls

Product Recall Tracker

Recall D-0358-2023

Description: 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.

Recall D-0358-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0358-2023
Event ID91749
DistributionNationwide in the USA
Quantity270,291 bottles
Recall ReasonLack of Assurance of Sterility
Drug ClassificationClass II
Drug Code Info20230308
Recall Initiation Date20230222
Report Date20230308
Classification Date20230227
Address4500 12th Street Ext
West Columbia, SC 29172-3025
United States
Recalling FirmNephron Sterile Compounding Center LLC
Initial Notification Letter
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