FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for E...
FDA Recall #D-0945-2023 — Class II — July 20, 2023
Product Description
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
Reason for Recall
cGMP deviations: due to shipment of rejected units.
Recalling Firm
SCA Pharmaceuticals — Windsor, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
183 bags
Distribution
KY and NJ
Code Information
Lot # 1223047134, Use By: 09/21/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated