FDA recall D-0830-2022
SCA Pharmaceuticals · Class II · drug
Product
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
Reason for recall
CGMP Deviations
Distribution
Product was distributed nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2022-04-25
- Report date
- 2022-05-11
- Termination date
- 2022-09-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Windsor, CT, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0830-2022