Cardioplegia Solution Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to lack of validation data for sanitization cycles, which cannot assure product sterility.
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: FDA Class II recall involving a risk-of-harm product (intravenous medication for cardiac surgery) with no reported illnesses or injuries. The hazard is theoretical but involves potential contamination due to unvalidated sterilization processes.
Plain-English summary
Cardioplegia Solution is a sterile intravenous medication used during cardiac surgery to protect the heart during cardiopulmonary bypass. Central Admixture Pharmacy Services, Inc. is recalling CARDIOPLEGIA SOLUTION, 25 mEq K (Lot 36-262542, expiring 8/25/2023) because the company lacks adequate validation data for its sanitization cycles to assure the product is sterile.
The recalled product (16 bags) was distributed nationwide. The absence of validated sanitization processes creates a potential risk that the product may not be sterile, which could pose a risk during cardiac surgery where this medication is administered directly into the circulatory system.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — IV Solution / Cardiac
- Affected units
- 16
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# 36-262542
- Exp 8/25/2023
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.
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