FDA-Drug2023-08-09Class II
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Hazard
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Sold states
Nationwide in the USA
Affected count
132 bags
Manufactured in
2200 S 43rd Ave, N/A, Phoenix, AZ, United States
Products
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1027-2023Don't want to check this manually?
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