PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 11, 2022 Initiated: April 25, 2022 #D-0830-2022

Product Description

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

Details

Recalling Firm
SCA Pharmaceuticals
Units Affected
424 bags
Distribution
Product was distributed nationwide within the United States
Location
Windsor, CT

Frequently Asked Questions

What product was recalled?
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. Recalled by SCA Pharmaceuticals. Units affected: 424 bags.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on May 11, 2022. Severity: Moderate. Recall number: D-0830-2022.