FDA-Drug2023-08-09Class II

CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total volume = 542 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0212-1

Central Admixture Pharmacy Services, Inc.
Hazard

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

Sold states
Nationwide in the USA
Affected count
192
Manufactured in
2200 S 43rd Ave, N/A, Phoenix, AZ, United States
Products
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total volume = 542 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0212-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1018-2023

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