FDA Recalls Cardioplegia Solution Due to Sterility Assurance Defect
Central Admixture Pharmacy Services, Inc. is recalling 140 bags of Cardioplegia Solution due to lack of assurance of sterility following an FDA inspection. 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: FDA Class II designation for lack of sterility assurance in a critical injectable product used in cardiac surgery. No illnesses or injuries have been reported and sterility breach has not been confirmed, but the potential for serious infection represents significant risk of harm in this high-risk surgical application.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL bags. The recall involves 140 bags distributed nationwide in the United States.
The product is being recalled due to lack of assurance of sterility. An FDA inspection raised questions about whether the sterile pharmaceutical product met required sterility standards. Cardioplegia solutions are used in cardiac surgical procedures.
The affected lot numbers are 37-896489 (expiration 05/07/2023), 37-897805 (expiration 05/12/2023), and 37-900959 (expiration 05/26/2023). Healthcare facilities with inventory from these lots should follow guidance from their regulatory authorities and contact the manufacturer for further instructions.
The recalled product
- Product
- Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0007-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / Surgical
- Affected units
- 140
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 (6)
- Lot # 37-896489
- Exp 05/07/2023
- 37-897805
- Exp 05/12/2023
- 37-900959
- Exp 05/26/2023
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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