SCA Pharmaceuticals, LLC recalls fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mc
Recalled April 3, 2024 · FDA recall D-0398-2024 · SCA Pharmaceuticals
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
613 Cassettes
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility
Product
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164
Manufacturer(s)
SCA Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →