labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

Code information: Lot # 1220022969, BUD 3/1/2021; 1220023002, BUD 3/2/2021; 1220023045, BUD 3/2/2021; 1220023081, BUD 3/2/2021; 1220023130, BUD 3/6/2021; 1220023229, BUD 3/9/2021; 1220023287, BUD 3/12/2021 & 1220023335, BUD 3/22/2021.

Distribution pattern: Product was distributed to hospitals nationwide.