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SCA Pharmaceuticals, LLC recalls fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/m

Recalled April 3, 2024 · FDA recall D-0399-2024 · SCA Pharmaceuticals

Hazard
Lack of Assurance of Sterility · FDA Class II
Units
324 syringes
Sold at
Nationwide in the USA

Description

Lack of Assurance of Sterility

Product
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
Manufacturer(s)
SCA Pharmaceuticals, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

SCA Pharmaceuticals, LLC recalls fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/m | RecallWatchUSA