Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot 36-254906) due to lack of assurance of sterility and missing validation data for 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 FDA Class II recall involves a risk-of-harm product (sterile IV solution used in cardiac surgery) with documented manufacturing deficiencies. No illnesses or injuries are reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 84 bags of Cardioplegia Solution (Lot 36-254906, expiring July 22, 2023) distributed nationwide in the United States. This intravenous solution is used during cardiac surgery to protect the heart during the procedure.
The FDA determined that the recalled product lacks assurance of sterility. The manufacturer's validation data for decontamination cycles is incomplete, which raises concerns about whether the product has been properly sterilized.
Healthcare providers who received this product should immediately stop using any bags from the recalled lot and verify they are not in patient care. Patients who received this product should contact their healthcare provider if they develop signs of infection, such as fever, chills, or other unusual symptoms following their procedure.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0108-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous Solution
- 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: 36-254906
- 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 failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22