fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422

Recall Number: D-0191-2021

Firm: SCA Pharmaceuticals

Classification: Class II

Status: Terminated

Report Date: 20210113

Initiation Date: 20201217

Termination Date: 20211102

Reason for Recall

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

Product Description

fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422