Product: Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
Reason for recall: Lack of Assurance of Sterility
Recall initiated: 20190912
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated