FDA recall D-1070-2023

Central Admixture Pharmacy Services Inc · Class II · drug

Product

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

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2023-07-17
Report date: 2023-08-09
Termination date: 2025-03-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1070-2023