Skip to content
Recall Observatory FDA recall evidence

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

D-0830-2022

April 25, 2022

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 90080
Status
Terminated
Classification
Class II
Quantity
424 bags
Official record key
drug-enforcement:D-0830-2022

Official wording

Reason: CGMP Deviations

Code information: Lot #: 1222035837, Exp. Date 22-Jul-22 Lot #: 1222035804, Exp. Date 25-Jul-22

Distribution pattern: Product was distributed nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations