Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 308 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterility assurance.
What this means for you
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 is an FDA Class II recall of a prescription-only sterile product. No illnesses or injuries have been reported, but products that cannot assure sterility when intended to be sterile are inherently risk-of-harm products, meeting the rubric criterion for High severity.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Maintenance 8:1 low potassium (24 mEq K), supplied in 500 mL bags. The recall affects 308 bags distributed nationwide. The affected lot numbers are 37-893846, 37-895704, 37-897079, 37-897927, 37-898814, and 37-900617, with expiration dates from April 28, 2023 through May 25, 2023.
An FDA inspection raised concerns about the sterility of these products intended to be sterile. The manufacturer was unable to provide adequate assurance of the products' sterility. This lack of sterility assurance for a prescription-only product represents a safety concern.
The recall affects healthcare facilities and hospitals nationwide that may have received this product. Facilities should contact Central Admixture Pharmacy Services, Inc., located at 6580 Snowdrift Road, Allentown, PA 18106, for guidance on the affected inventory.
The recalled product
- Product
- Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0105-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Cardioplegia Solution
- Hazard
- sterility-assurance-failure
- contamination-risk
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 (12)
- Lot # 37-893846
- Exp 04/28/2023
- 37-895704
- Exp 05/05/2023
- 37-897079
- Exp 05/11/2023
- 37-897927
- Exp 05/13/2023
- 37-898814
- Exp 05/18/2023
- 37-900617
- Exp 05/25/2023
Distribution
Distributed nationwide across the United States.
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