Product: Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
Reason for recall: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated: 20201217
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated