Product Safety Recalls

Product Recall Tracker

Recall D-0945-2023

Description: 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

Recall D-0945-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0945-2023
Event ID92737
DistributionKY and NJ
Quantity183 bags
Recall ReasoncGMP deviations: due to shipment of rejected units.
Drug ClassificationClass II
Drug Code Info20230802
Recall Initiation Date20230720
Report Date20230802
Classification Date20230726
Address755 Rainbow Rd Ste B
Windsor, CT 06095-1024
United States
Recalling FirmSCA Pharmaceuticals
Initial Notification Letter
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