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Recall Observatory FDA recall evidence

Drug product

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.

D-0065-2023

November 10, 2022

Class II

Product summary

Firm
Nephron Sterile Compounding Center LLC
Event
Event 91132
Status
Terminated
Classification
Class II
Quantity
56,220 vials
Official record key
drug-enforcement:D-0065-2023

Official wording

Reason: CGMP Deviations: Potential for cross contamination due to product carry over.

Code information: Lots: NE1062A, NE1062B Exp. 12/02/2022; NE1065A, NE1065B Exp. 12/13/2022; NE2011A, NE2011B Exp. 03/15/2022.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations