Cardioplegia Solution Recalled Due to Lacking Decontamination Validation Data
A cardioplegia solution is being recalled nationwide because the manufacturer lacks validation data for decontamination cycles, raising sterility assurance concerns. Affected lots: 36-254401 and 36-257070.
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 illnesses or injuries. This is a risk-of-harm product (surgical medication) where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, 36 mEq K, Induction 4:1, IV Bag (500 mL) distributed nationwide. Approximately 212 bags are affected.
The recall is due to lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Affected lot numbers are 36-254401 (expiration 7/21/2023) and 36-257070 (expiration 7/31/2023). Users should cease using affected lots and contact the manufacturer for return or disposal instructions.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 36 mEq K, Induction 4:1, High Potassium/Low tromethamine, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0101-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV
- Affected units
- 212
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: 36-254401
- Exp. 7/21/2023
- 36-257070
- Exp. 7/31/2023
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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