Product Safety Recalls

Product Recall Tracker

Recall D-0065-2023

Description: PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.

Recall D-0065-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0065-2023
Event ID91132
DistributionNationwide in the USA
Quantity56,220 vials
Recall ReasonCGMP Deviations: Potential for cross contamination due to product carry over.
Drug ClassificationClass II
Drug Code Info20221123
Recall Initiation Date20221110
Report Date20221123
Classification Date20221117
Address4500 12th Street Ext
West Columbia, SC 29172-3025
United States
Recalling FirmNephron Sterile Compounding Center LLC
Initial Notification Letter
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