FDA-Drug2022-08-24Class II
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
Nephron Sterile Compounding Center LLC
Hazard
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Sold states
Nationwide in the USA
Affected count
33,870 vials
Manufactured in
4500 12th Street Ext, West Columbia, SC, United States
Products
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1347-2022Don't want to check this manually?
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