FDAFDA · Food and drugs·Recall number D-0064-2023
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.
Published November 23, 2022 · Recall initiated: November 10, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Potential for cross contamination due to product carry over.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Distributor
- Nationwide in the USA
- Lot
- Lots: LB2001B Exp. 01/07/2023; LB2005B Exp. 03/02/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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