PlainRecalls
FDA Drug Moderate Class II Terminated

fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1

Reported: August 9, 2023 Initiated: July 17, 2023 #D-1070-2023

Product Description

fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1

Reason for Recall

Lack of assurance of sterility: Lack of validation data for sanitization cycles

Details

Units Affected
1,114 bags
Distribution
Nationwide in the USA
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1. Recalled by Central Admixture Pharmacy Services Inc. Units affected: 1,114 bags.
Why was this product recalled?
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Which agency issued this recall?
This recall was issued by the FDA Drug on August 9, 2023. Severity: Moderate. Recall number: D-1070-2023.