Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling 132 bags of Cardioplegia Solution (Lot 36-254403) nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles used in the manufacturing process.
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 is an FDA Class II recall of an injectable product with unvalidated sterilization and decontamination processes, creating a risk of microbial contamination in a product used during invasive cardiac surgery. No illnesses or injuries have been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 132 bags of Cardioplegia Solution, HIGH K, Induction 4:1, Plasmalyte/Tromethamine (a high-potassium IV bag with 500 mL total volume, NDC 72196-0111-1, Lot 36-254403, Exp. 7/21/2023) distributed nationwide in the United States.
The recall was issued due to lack of assurance of sterility. Specifically, validation data for the decontamination cycles used in the manufacturing process is lacking, raising concerns about whether the product has been properly sterilized.
Cardioplegia solution is used during cardiac surgery to stop the heart. Healthcare facilities and physicians who received this product should immediately discontinue use and quarantine any remaining inventory. Patients who may have received this product should contact their healthcare provider.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Solution
- Hazard
- sterility-defect
- manufacturing-defect
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: 36-254403
- Exp. 7/21/2023
Distribution
Distributed nationwide across the United States.
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