Date: 07/20/2023
Product: FentaNYL 500 mcg/250 mL – Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration – 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Company: SCA Pharmaceuticals
Recall Reason: cGMP deviations: due to shipment of rejected units.
Classification: Class II
Report Date: 20230802