D-0945-2023 Class II Terminated
FDA drug recall D-0945-2023 was initiated by SCA Pharmaceuticals on July 20, 2023 and is designated Class II. Reason for recall: cGMP deviations: due to shipment of rejected units. The recall status is terminated (terminated September 21, 2023). Affected quantity: 183 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- August 2, 2023
- Initiation Date
- July 20, 2023
- Termination Date
- September 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 183 bags
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
Reason for Recall
cGMP deviations: due to shipment of rejected units.
Distribution Pattern
KY and NJ
Code Information
Lot # 1223047134, Use By: 09/21/2023