FDA Recalls Cardioplegia Solution Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 184 units of Cardioplegia Solution nationwide due to lack of validation data for sterilization cycles, which compromises sterility assurance in this injectable cardiac medication.
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 for a sterility assurance defect in an injectable cardiac medication. While the quality defect is serious and poses risk of serious harm to patients, no illnesses or hospitalizations have been reported in the source material.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 184 units of Cardioplegia Solution, 60 mEq K, Induction 4:1, in 830 mL EVA bags. The recall affects two lot numbers: Lot 36-262513 (expiration 8/25/2023) and Lot 36-262880 (expiration 8/27/2023). The products were distributed nationwide throughout the USA.
The recall was initiated due to lack of assurance of sterility resulting from inadequate validation data for sanitization cycles. This means the manufacturing sterilization processes were not adequately validated to ensure the product is sterile.
Cardioplegia solution is an injectable medication administered during cardiac surgery. When sterilization processes lack validation, there is a risk that the product may not be sterile, which could result in serious infection or other complications if administered to patients.
Healthcare facilities and providers should immediately check their inventory for these lot numbers and discontinue use of any units found. Contact Central Admixture Pharmacy Services, Inc. for information regarding product returns, replacement, or further instructions.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Cardioplegia Solution
- Affected units
- 184
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 (4)
- Lot# 36-262513
- Exp 8/25/2023
- 36-262880
- Exp 8/27/2023
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 · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- 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
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighFDA Recalls Cardioplegia Solution for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighFDA Recalls Cardioplegia Solution for Lacking Sterility Validation Data
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 Failure
FDA (Drugs) · 2023-08-09
- HighFDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-05-31
- HighCardioplegia Solution Recalled Due to Sterility Assurance Deficiency
FDA (Drugs) · 2023-08-09