Cardioplegia Solution 122 mEq K Recalled for Sterility Failure
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination. The product was distributed nationwide.
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: This is an FDA Class II recall for a critical-use cardiac drug. No illnesses or injuries are reported in the source. Per the rubric, risk-of-harm products without reported injury score at 3 (High).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution 122 mEq K in 1000 mL IV bags. The recalled lot is 36-256332, expiring 7/29/2023. A total of 80 bags were distributed nationwide.
The FDA initiated this recall because the manufacturer lacks assurance of sterility and validation data for the decontamination cycles used to prepare the product. This creates a risk that the product may not be sterile.
Hospitals, surgical centers, and other healthcare facilities using this product should immediately stop use of the affected lot and contact Central Admixture Pharmacy Services or the FDA for guidance on replacement or alternatives.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0209-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Cardiac / IV Solution
- 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:36-256332
- Exp. 7/29/2023.
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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