FDA-Drug2023-08-02Class II
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
SCA Pharmaceuticals
Hazard
cGMP deviations: due to shipment of rejected units.
Sold states
KY and NJ
Affected count
183 bags
Manufactured in
755 Rainbow Rd Ste B, N/A, Windsor, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0945-2023Don't want to check this manually?
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