FDAFDA · Food and drugs·Recall number D-0961-2022
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
Published June 8, 2022 · Recall initiated: May 18, 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
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Distributor
- Nationwide in the USA
- Lot
- Lots: LB1020A, LB1022A Exp. 5/21/2022; LB2003A, Exp. 8/5/2022; LB2007A, Exp. 9/20/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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