Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 144 bags of Cardioplegia Solution nationwide because validation data for sterilization cycles is lacking.
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 FDA Class II recall involves a sterile surgical medication with unvalidated sterilization processes. Though no illnesses or injuries have been reported, the theoretical risk of contamination in a critical-use product constitutes a risk-of-harm situation. Per the rubric, without reported illness, the maximum score is 3.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution (Modified St. Thomas Solution, 106 mEq K, 1000 mL IV bags, NDC: 72196-0204-1) nationwide in the United States. The recall affects 144 bags from two lots: Lot 36-253949 (expiration 7/20/2023) and Lot 36-255411 (expiration 7/23/2023).
The product is being recalled due to lack of assurance of sterility. The manufacturer lacks validation data for decontamination cycles, meaning the sterilization of the product cannot be confirmed.
Cardioplegia solutions are sterile intravenous products used during cardiac surgery. If contaminated, they pose a serious health risk to patients receiving the medication.
If you have received this product, do not use it. Contact your healthcare provider or Central Admixture Pharmacy Services, Inc. at 2200 South 43rd Avenue, Phoenix, AZ 85043 for instructions on return or disposal.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0204-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Sterile Injectable
- Affected units
- 144
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 (4)
- Lot:36-253949
- Exp. 7/20/2023
- 36-255411
- Exp. 7/23/2023.
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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