FDA-Drug2024-04-03Class II
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
SCA Pharmaceuticals, LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide in the USA
Affected count
613 Cassettes
Manufactured in
755 Rainbow Rd Ste B, N/A, Windsor, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0398-2024Don't want to check this manually?
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