FDA recall D-1031-2023

Product

CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0107-1

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-1031-2023