Cardioplegia Solution Recalled for Unvalidated Sterilization Process
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of validated sterilization processes used during its manufacture.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a high-risk sterile injectable used in critical cardiac procedures. No illnesses have been reported, but the hazard—unvalidated sterilization assurance—poses a significant risk of contamination and potential serious harm if microorganisms are present, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution 24 mEq K Maintenance 8:1 (Low Potassium), 500 mL in EVA bags (NDC 72196-0105-1) due to lack of assurance of sterility. The recall affects Lot 36-262516, which has an expiration date of 8/25/2023. Approximately 84 bags were distributed nationwide.
The product was recalled because the manufacturer could not provide validation data demonstrating that the sanitization cycles used during production were adequate to ensure the sterility of the solution. Without validated sterilization assurance, the product could potentially be contaminated with microorganisms.
Cardioplegia solution is a prescription medication administered directly into the heart during cardiac surgery to induce and maintain cardioplegic arrest. If contaminated, such a solution could cause serious infection or other complications in cardiac surgery patients.
Healthcare providers and hospitals should stop using any units from the affected lot. Patients who may have received this product should consult their healthcare provider if they experience signs of infection or other complications.
The recalled product
- Product
- 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
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug
- Affected units
- 84
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 36-262516
- Exp 8/25/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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