FDA-Drug2022-11-23Class II
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.
Nephron Sterile Compounding Center LLC
Hazard
CGMP Deviations: Potential for cross contamination due to product carry over.
Sold states
Nationwide in the USA
Affected count
34,020 vials
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0064-2023Don't want to check this manually?
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