fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122

Recall Number: D-0192-2021

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

fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122