FDA recall D-1048-2023

Central Admixture Pharmacy Services Inc · Class II · drug

Product

vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6012-1.

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-1048-2023