FDA-Drug2023-08-09Class II

CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0108-1

Hazard

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

Sold states
Nationwide in the USA
Affected count
84 bags
Manufactured in
2200 S 43rd Ave, N/A, Phoenix, AZ, United States
Products
CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0108-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1039-2023

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