labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028

Recall Number: D-0411-2024

Firm: SCA Pharmaceuticals, LLC

Classification: Class II

Status: Terminated

Report Date: 20240403

Initiation Date: 20231109

Termination Date: 20240827

Lack of Assurance of Sterility

labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028