Cardioplegia Solution IV bags recalled for missing sterility validation
Central Admixture Pharmacy Services is recalling Cardioplegia Solution IV bags (Lot 36-252142) nationwide because decontamination validation data is lacking, preventing assurance of 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 of a critical sterile injectable. No reported illnesses or injuries, and the hazard is assurance-related rather than confirmed contamination. Scores at High per rubric for Class II recalls without reported harm.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, 15 mEq K, Reperfusate 4:1, in IV bags with a total volume of 477.5 mL. Approximately 80 bags of lot 36-252142 (expiration July 16, 2023) were distributed nationwide.
The recall was issued because validation data for decontamination cycles is lacking, preventing assurance that the product is sterile. Sterility is essential for injectable medications used in cardiac surgery.
No illnesses or injuries have been reported in connection with this product.
Patients and healthcare providers who believe they have received affected product should contact Central Admixture Pharmacy Services, Inc., located at 2200 South 43rd Avenue, Phoenix, AZ 85043.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0008-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- Affected units
- 80
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: 36-252142
- Exp. 7/16/2023.
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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