PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022

Recall Number: D-0216-2021

Firm: SCA Pharmaceuticals

Classification: Class II

Status: Terminated

Report Date: 20210113

Initiation Date: 20201217

Termination Date: 20211102

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

PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022