FDAFDA · Food and drugs·Recall number 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, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Published August 2, 2023 · Recall initiated: July 20, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: due to shipment of rejected units.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SCA Pharmaceuticals
- Distributor
- KY and NJ
- Lot
- Lot # 1223047134, Use By: 09/21/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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