FDA-Drug2023-09-06Class II

CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1

Central Admixture Pharmacy Services, Inc.
Hazard

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Sold states
Nationwide in the USA
Affected count
304 bags
Manufactured in
2200 S 43rd Ave, N/A, Phoenix, AZ, United States
Products
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1107-2023

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