CLASS II Drug recall · Reported 6 Sep 2023 · FDA Enforcement Report
Cardioplegia Solution, 24 mEq K, Maintenance 8:1 recalled
Central Admixture Pharmacy Services is recalling Cardioplegia Solution, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume =, Eva, distributed nationwide in the US. The recall was initiated on 17 Aug 2023 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes Lot# 36-262516, Exp 8/25/2023.
Quantity recalled 84 bags
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Recall number D-1110-2023
FDA event ID 92898
Classification Class II
Status Terminated
Recall initiated 17 Aug 2023
FDA classified 28 Aug 2023
Reported 6 Sep 2023
Type Voluntary: Firm initiated
Customers notified by Letter
Timeline
17 Aug 2023 Recall initiated by company 28 Aug 2023 Classified by FDA +11 days 6 Sep 2023 Published in enforcement report +9 days
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Nationwide
Questions about this recall
Why was it recalled? Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Which lots are affected? Lot# 36-262516, Exp 8/25/2023.
Where was it sold? Nationwide in the USA
What should I do if I have it? Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean? Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event 31 other products · FDA event 92898 This product is part of a recall event; the main page for the event is EPINEPHrine added to dextrose 5%, 4mg/ (16 mcg/mL), IV recalled .
Reported Class Recall Company Reason Where 6 Sep 2023 CLASS II EPINEPHrine added to dextrose 5%, 4mg/ (16 mcg/mL), IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II EPINEPHrine, 2 mg added to dextrose 5%, Concentration = 8 mcg/mL, IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II heparin added to 0.9% sodium chloride/mL), IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II PHENYLephrine added to 0.9% sodium chloride 50 mg/ (200mcg/mL), IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Cardioplegia Solution, High K, Induction 4:1 recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II oxyTOCIN added to 0.9% sodium chloride, IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II PHENYLephrine added to 0.9% sodium chloride, 20mg/ (80 mcg/mL), IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II PHENYLephrine, added to 0.9% sodium chloride, 10mg/ (40mcg/mL), IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II dilTIAZem 125mg/ (1 mg/mL), added to 0.9% sodium chloride, IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Cardioplegia Solution, 25 mEq K, Sutter Cardioplegia recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II vancomycin added to 0.9% Sodium Chloride (5 mg/mL) Excel recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Cardioplegia Solution, 60 mEq K, Induction 4:1 recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II oxyTOCIN added to Lactated Ringer's, IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II oxyTOCIN added to 0.9% sodium chloride, IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II PHENYLephrine 1,000 mcg/, (100mcg/mL) recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II rocuronium 50 mg/ (10 mg/mL) Syringes recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II PHENYLephrine, added to 0.9% sodium chloride, 40mg/ (160mcg/mL), IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Cardioplegia Solution del Nido Formula, Total Volume =, EVA recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Cardioplegia Solution, 20 mEq K, Maintenance 4:1 recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II dilTIAZem 125mg/ (1 mg/mL), added to dextrose 5%, IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II EPINEPHrine added to 0.9% sodium chloride, 4mg/ (16 mcg/mL), IV recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 CLASS II Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy Central Admixture Pharmacy Services Sterility Nationwide
More recalls from Central Admixture Pharmacy Services All 347
Other Cardioplegia recalls All 59 Reported Class Recall Company Reason Where 6 Sep 2023 Drug CLASS II Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 Drug CLASS II Cardioplegia Solution, 20 mEq K, Maintenance 4:1 recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 Drug CLASS II Cardioplegia Solution, 60 mEq K, Induction 4:1 recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 Drug CLASS II Cardioplegia Solution, 25 mEq K, Sutter Cardioplegia recalled Central Admixture Pharmacy Services Sterility Nationwide 6 Sep 2023 Drug CLASS II Cardioplegia Solution, High K, Induction 4:1 recalled Central Admixture Pharmacy Services Sterility Nationwide