MedicineWatch US
Class II Recall

Nephron Sterile Compounding Center LLC

Product
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
Reason
Lack of Assurance of Sterility
Classification
Class II
Status
Terminated
Lot
Lots: LB1020A, LB1022A Exp. 5/21/2022; LB2003A, Exp. 8/5/2022; LB2007A, Exp. 9/20/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.