Recall Enforment Report D-0064-2023

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Nephron Sterile Compounding Center LLC, originally initiated on 11-10-2022 for the product PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6. The product was recalled due to cgmp deviations: potential for cross contamination due to product carry over.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0064-202311-10-202211-23-2022Class II34,020 vialsPF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.CGMP Deviations: Potential for cross contamination due to product carry over.Ongoing
D-0065-202311-10-202211-23-2022Class II56,220 vialsPF-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.CGMP Deviations: Potential for cross contamination due to product carry over.Ongoing