SCA Pharmaceuticals, LLC recalls fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg
Recalled April 3, 2024 · FDA recall D-0401-2024 · SCA Pharmaceuticals
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
130 cassettes
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility
Product
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164
Manufacturer(s)
SCA Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →