FDA Recalls Cardioplegia Solution Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 226 bags of Cardioplegia Solution due to lack of assurance of sterility following FDA inspection. No illnesses reported.
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 involving a sterile injectable product where sterility assurance was questioned during FDA inspection. No illnesses or injuries reported, limiting severity to 3 per rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 226 bags of Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, packaged in 1047 mL per bag (NDC 71285-0211-1), due to lack of assurance of sterility.
The product is being recalled after an FDA inspection called into question the sterility of these products, which are intended to be sterile. Cardioplegia solution is a medication used during cardiac surgery to preserve the heart during the procedure.
The recalled product was distributed nationwide in the USA. The affected lot numbers are: 37-894309 and 37-894321 (Exp 04/29/2023), 37-896159 (Exp 05/06/2023), 37-898510 (Exp 05/15/2023), and 37-900324 (Exp 05/22/2023).
No illnesses or injuries have been reported in connection with this recall. Healthcare providers and facilities with affected product should contact Central Admixture Pharmacy Services, Inc. for guidance.
The recalled product
- Product
- Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, low K, packaged in 1047 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0211-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / Cardioplegia
- Hazard
- sterility-assurance
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 (9)
- Lot # 37-894309
- 37-894321
- Exp 04/29/2023
- 37-896159
- Exp 05/06/2023
- 37-898510
- Exp 05/15/2023
- 37-900324
- Exp 05/22/2023
Distribution
Distributed nationwide across the United States.
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