Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of sterility assurance and insufficient validation data for sterilization decontamination cycles.
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: This is a Class II recall of an injectable medical product with a gap in sterility assurance. No illnesses or injuries have been reported. The hazard is potential microbial contamination due to validation gaps in sterilization processes, which fits the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling a cardioplegia solution (Lot 36-254914, expiring July 22, 2023) distributed nationwide. The product is a 500 mL injectable solution used during cardiac surgery.
The recall was initiated because the manufacturer lacks assurance the product meets sterility standards. Validation data for the decontamination cycles used during sterilization is insufficient.
All 28 bags of the affected lot were distributed nationwide. Healthcare facilities that received this product should discontinue use and confirm that no units from this lot have been administered to patients.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 28
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: 36-254914
- Exp. 7/22/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 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 95 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
- HighInjectable Lidocaine Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighMidazolam Injectable Solution Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2023-10-11
Same hazard · sterility assurance failure
See all →- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
- SevereTirzepatide/Cyanocobalamin Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2025-07-02
- HighOmnicell IVX Station Reconstitution Transfer Sets Recall
FDA (Devices) · 2025-04-16
- HighCompounded Fentanyl and Bupivacaine Epidural Injections Recalled for Sterility Assurance
FDA (Drugs) · 2025-04-02
- HighInjectable Phenylephrine Recall Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-03