SCA Pharmaceuticals recalls FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL C
Recalled August 2, 2023 · FDA recall D-0945-2023 · SCA Pharmaceuticals
Hazard
cGMP deviations: due to shipment of rejected units. · FDA Class II
Units
183 bags
Sold at
KY and NJ
Description
cGMP deviations: due to shipment of rejected units.
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
Manufacturer(s)
SCA Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →