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FDARecalled Aug 2, 2023 · #D-0945-2023

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...

Hazard

Class II — temporary health risk

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Description

cGMP deviations: due to shipment of rejected units. Classification: Class II Distribution: KY and NJ

Product details

Product
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
Type
Drugs
Manufacturer
SCA Pharmaceuticals
Model numbers
1223047134
UPCs