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

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

Code information: Lot # 1220022911, BUD 1/18/2021; 1220023092, BUD 1/25/2021 & 1220023247, BUD 1/27/2021.

Distribution pattern: Product was distributed to hospitals nationwide.