Product: Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205
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