FDA recall D-1069-2023

Product

fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1

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-1069-2023