PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: November 23, 2022 Initiated: November 10, 2022 #D-0065-2023

Product 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.

Reason for Recall

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

Details

Units Affected
56,220 vials
Distribution
Nationwide in the USA
Location
West Columbia, SC

Frequently Asked Questions

What product was recalled?
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.. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 56,220 vials.
Why was this product recalled?
CGMP Deviations: Potential for cross contamination due to product carry over.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 23, 2022. Severity: Moderate. Recall number: D-0065-2023.