FDA-Drug2023-08-09Class II
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
Hazard
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Sold states
Nationwide in the USA
Affected count
356 bags
Manufactured in
2200 S 43rd Ave, N/A, Phoenix, AZ, United States
Products
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1037-2023Don't want to check this manually?
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