Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009

Recall Number: D-0217-2021

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

Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009