FDA Recalls Cardioplegia Solution Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 267 bags of Cardioplegia Solution after FDA inspection raised questions about sterility assurance. The prescription product was distributed nationwide.
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 due to lack of sterility assurance in a product intended to be sterile. No illnesses or injuries have been reported, but the theoretical risk from potential contamination justifies a High severity rating per the rubric's criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Induction 4:1, High Potassium (60 mEq K), packaged in 830 mL bags. The affected product includes 267 bags with lot numbers 37-894304, 37-894946, 37-896482, 37-897933, and 37-900461, with expiration dates ranging from April 29, 2023 through May 22, 2023, distributed nationwide in the USA.
The recall was initiated after an FDA inspection called into question the sterility of products intended to be sterile. This is an FDA Class II recall involving a prescription pharmaceutical product. Lack of adequate sterility assurance in products intended for medical administration poses a potential risk of contamination.
Healthcare providers and facilities that received this product should stop using the affected lots immediately and contact Central Admixture Pharmacy Services for further guidance. Patients or healthcare providers with questions about affected units should consult their healthcare provider or the manufacturer for instructions.
The recalled product
- Product
- Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0100-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 267
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 (10)
- Lot # 37-894304
- Exp 04/29/2023
- 37-894946
- Exp 05/01/2023
- 37-896482
- Exp 05/07/2023
- 37-897933
- Exp 05/13/2023
- 37-900461
- Exp 05/22/2023
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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