Cardioplegia Solution Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to lack of validation data for sanitization cycles, which cannot assure product sterility.
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 involving a risk-of-harm product (intravenous medication for cardiac surgery) with no reported illnesses or injuries. The hazard is theoretical but involves potential contamination due to unvalidated sterilization processes.
Plain-English summary
Cardioplegia Solution is a sterile intravenous medication used during cardiac surgery to protect the heart during cardiopulmonary bypass. Central Admixture Pharmacy Services, Inc. is recalling CARDIOPLEGIA SOLUTION, 25 mEq K (Lot 36-262542, expiring 8/25/2023) because the company lacks adequate validation data for its sanitization cycles to assure the product is sterile.
The recalled product (16 bags) was distributed nationwide. The absence of validated sanitization processes creates a potential risk that the product may not be sterile, which could pose a risk during cardiac surgery where this medication is administered directly into the circulatory system.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — IV Solution / Cardiac
- Affected units
- 16
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# 36-262542
- 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.
See all 32 products in this recall →Related recalls
Same manufacturer · Central Admixture Pharmacy Services, Inc.
See all →- ModeratePediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
- SeverePediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
- SevereInjectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
- HighEphedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighFentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11
Same hazard · contamination risk
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Vancomycin Injection Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
Similar recalls
- HighCardioplegia Solution Recalled Due to Sterility Assurance Deficiency
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighCardioplegia IV Solution Recalled for Sterilization Validation Deficiency
FDA (Drugs) · 2023-08-09