FDA Recalls Cardioplegia Solution for Lacking Sterility Validation Data
Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products distributed nationwide.
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: This is an FDA Class II recall due to inadequate validation of sterilization processes for an intravenous cardiac solution. The lack of sterility assurance in a critical-care injectable product creates a significant risk of pathogenic contamination. This risk-of-harm scenario, absent reported illnesses, merits a High severity rating per the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling a cardioplegia solution used during open-heart surgery. The product is a 300 mL intravenous (IV) bag of Cardioplegia Solution containing 24 mEq potassium (K) in an 8:1 formulation, requiring a prescription. The recall affects 104 bags distributed nationwide in the United States.
The recall was issued because the manufacturer lacks sufficient validation data for sterilization decontamination cycles. Without documented validation, there is no assurance that the solution is sterile before use. A contaminated sterile IV solution used directly in cardiac surgery could introduce pathogens into the bloodstream, creating a risk of infection during or after the procedure.
Two lot numbers are affected: Lot 36-254125 (expiring July 20, 2023) and Lot 36-256034 (expiring July 28, 2023). The product is identified by NDC 72196-0215-1 and was manufactured by Central Admixture Pharmacy Services, Inc., located in Phoenix, Arizona.
Healthcare facilities and hospitals that received this product should immediately cease use and quarantine affected inventory. Contact the manufacturer or the FDA for information regarding verification, replacement, or refunds.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 104
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: 36-254125
- Exp. 7/20/2023
- 36-256034
- Exp. 7/28/2023.
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.
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