The Recall Desk
HighFDA (Drugs)·D-1110-2023·Announced 2023-09-06

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.

What this means for you

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
Hazard
  • sterilization-failure
  • contamination-risk

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.

Related recalls

Same category