FDA recall D-1058-2023

Central Admixture Pharmacy Services Inc · Class II · drug

Product

HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1

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-1058-2023