FDA recall D-1063-2023

Product

fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1

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-1063-2023