Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling its Cardioplegia Solution after an FDA inspection raised concerns about product sterility. The recall affects 333 bags 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 recall fits the 'risk-of-harm products where injury has not yet been reported' criterion. It is an FDA Class II recall of a sterile injectable product with documented sterility assurance issues but no reported illnesses or injuries.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Induction 4:1 in Ringer's solution with high potassium (48 mEq K), packaged in 522.8 mL bags. The product is used during cardiac surgery to protect the heart muscle during bypass procedures.
The recall was initiated after an FDA inspection determined that the manufacturer could not assure the sterility of the product. Cardioplegia solutions must be sterile for safe use, as they are administered directly into the heart.
The affected product includes 333 bags distributed nationwide. The specific lots affected are: Lot #37-894326 (Exp 04/29/2023), Lot #37-895212 (Exp 05/04/2023), Lot #37-896794 (Exp 05/08/2023), Lot #37-897286 (Exp 05/12/2023), and Lot #37-899267 (Exp 05/19/2023).
Healthcare facilities and professionals who have received this product should stop using it immediately and contact Central Admixture Pharmacy Services, Inc. for instructions on return and replacement. Patients scheduled for cardiac surgery should consult with their surgical team if they have concerns about the products being used in their procedures.
The recalled product
- Product
- Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0206-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug
- Hazard
- Affected units
- 333
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 (10)
- Lot # 37-894326
- Exp 04/29/2023
- 37-895212
- Exp 05/04/2023
- 37-896794
- Exp 05/08/2023
- 37-897286
- Exp 05/12/2023
- 37-899267
- Exp 05/19/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 108 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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