Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of sterility assurance and missing validation data for manufacturing decontamination cycles.
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 drug recall for a sterile injectable product used in cardiac surgery with significant potential for harm if contaminated. No illnesses, injuries, or deaths have been reported. Per the rubric, recalls without reported illness and with theoretical hazard risk score at most 3.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, in 500 mL IV bags. This product is used during cardiac surgical procedures.
The recall was initiated because the company lacks assurance of sterility. Validation data for decontamination cycles is lacking, which prevents verification that the manufacturing process adequately removes microorganisms from the product.
Lot 36-255940, with an expiration date of July 27, 2023, was affected. Fifty-six bags were distributed nationwide in the United States.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0102-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Pharmaceutical
- Hazard
- Affected units
- 56
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: 36-255940
- Exp. 7/27/2023
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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