FDA recall D-1109-2023

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

Product

CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1

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: 2023-08-17
Report date: 2023-09-06
Termination date: 2025-03-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1109-2023