Cardioplegia Solution Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 476 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterile 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: FDA Class II recall concerning sterile assurance of a pharmaceutical product intended for intraoperative use. No illnesses or injuries have been reported. The hazard is theoretical but significant, meeting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine (low potassium) packaged in 1000 mL bags. The recall affects 476 bags distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. An FDA inspection called into question whether the products, which are intended to be sterile, actually maintained their sterile assurance. This is classified as a Class II recall.
The recalled product includes the following lot numbers and expiration dates: Lot # 37-894300 (Exp 04/29/2023), 37-896114 (Exp 05/06/2023), 37-896417 (Exp 05/07/2023), 37-897388 (Exp 05/12/2023), 37-898798 (Exp 05/18/2023), and 37-899618 (Exp 05/20/2023). The product was manufactured by Central Admixture Pharmacy Services, Inc., located in Allentown, PA.
The recalled product
- Product
- Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Sterile Pharmaceutical
- Hazard
- lack-of-sterility-assurance
- 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 # 37-894300
- Exp 04/29/2023
- 37-896114
- Exp 05/06/2023
- 37-896417
- Exp 05/07/2023
- 37-897388
- Exp 05/12/2023
- 37-898798
- Exp 05/18/2023
- 37-899618
- Exp 05/20/2023
Distribution
Distributed nationwide across the United States.
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