FentaNYL 500 mcg/ - Bupivacaine HCl 0 recalled over manufacturing violations

Recall date

July 20, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SCA Pharmaceuticals recalls FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL…

Recall number

D-0945-2023

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals

Sold / distributed

KY and NJ

Why it was recalled

cGMP deviations: due to shipment of rejected units.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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