FDA-Drug2023-09-06Class II

CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1

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
84 bags
Manufactured in
2200 S 43rd Ave, N/A, Phoenix, AZ, United States
Products
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1110-2023

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