FDA Recalls Cardioplegia Solution for Lack of Sterility Assurance
The FDA has recalled Central Admixture Pharmacy Services' Cardioplegia Solution 40 mEq K due to insufficient validation data for sterilization processes. The 80-bag lot may not meet sterility standards required for cardiac use.
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 with no reported hospitalizations or illnesses. The hazard is lack of sterility assurance in an injectable medication—a risk-of-harm product where injury has not yet been reported, matching the High (score 3) criterion.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution 40 mEq K, Warm Induction 4:1 High Potassium (500 mL IV bags). The affected lot is 36-252143 with expiration date 7/16/2023. A total of 80 bags were distributed nationwide.
The recall is due to insufficient assurance of sterility. Validation data for decontamination cycles used in manufacturing is lacking, meaning the product may not meet the sterility standards required for safe use as an injectable medication.
Healthcare providers and facilities that received this lot should stop using affected bags. For additional information about this recall, contact Central Admixture Pharmacy Services, Inc. at 2200 South 43rd Avenue, Phoenix, AZ 85043, or the FDA.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — IV Injectable
- 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: 36-252143
- 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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