FDA recall D-0947-2023

Central Admixture Pharmacy Services, Inc. · Class II · drug

Product

rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.

Reason for recall

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2023-07-14
Report date
2023-08-09
Termination date
2025-03-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0947-2023