Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (Reperfusate No Potassium) due to lack of assurance of sterility identified during FDA inspection.
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 of a sterile injectable product with no reported illnesses or injuries. This meets the criterion of 'risk-of-harm products where injury has not yet been reported,' warranting severity 3 (High), particularly given the critical use of cardioplegia solutions in cardiac surgery.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL bags (NDC 71285-0006-1). The recall affects 151 bags distributed nationwide in the USA, including lot numbers 37-895691 (expiring 05/05/2023), 37-896792 (expiring 05/08/2023), and 37-899170 (expiring 05/19/2023). The product is manufactured by Central Admixture Pharmacy Services, Inc., located at 6580 Snowdrift Road, Allentown, PA 18106. This is an Rx-only sterile product.
The recall was initiated after an FDA inspection raised concerns about the lack of assurance of sterility for products intended to be sterile.
Healthcare facilities and providers who have the affected lots should not use the product. Patients who may have received this product should contact their healthcare provider for guidance.
The recalled product
- Product
- Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0006-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Sterile Injectable
- Hazard
- Affected units
- 151
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 # 37-895691
- Exp 05/05/2023
- 37-896792
- Exp 05/08/2023
- 37-899170
- 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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