SCA Pharmaceuticals: Drug Recall
Recall #D-0945-2023 · 07/20/2023
Class II: Risk
Recall Details
- Recall Number
- D-0945-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- SCA Pharmaceuticals
- Status
- Terminated
- Date Initiated
- 07/20/2023
- Location
- Windsor, CT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 183 bags
Reason for Recall
cGMP deviations: due to shipment of rejected units.
Product 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
Distribution Pattern
KY and NJ
Other Recalls by SCA Pharmaceuticals
- Class III: Low Risk 04/10/2023
- Class III: Low Risk 02/24/2023
- Class II: Risk 04/25/2022
- Class II: Risk 04/25/2022
- Class II: Risk 04/25/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.