Cardioplegia Solution Recalled Due to Insufficient Sterility Assurance
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lacking validation data for decontamination cycles, creating insufficient assurance of sterility in this injectable product.
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 of a sterile injectable product with insufficient assurance of sterility due to inadequate decontamination validation. The hazard is substantial but no illnesses or injuries have been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution (12 mEq K, Maintenance 4:1 in Ringer's Low Potassium) distributed as 504.8 mL IV bags (NDC 72196-0205-1). The recall is due to lack of assurance of sterility caused by missing validation data for decontamination cycles.
Affected lot numbers are 36-253948 (expiration 7/20/2023) and 36-255217 (expiration 7/23/2023). A total of 172 bags were distributed nationwide in the USA. The manufacturer is located at 2200 South 43rd Avenue, Phoenix, AZ 85043.
Healthcare providers and institutions that received this product should review the recall and consult with the manufacturer regarding affected inventory.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0205-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-defect
- 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 (4)
- Lot: 36-253948
- Exp. 7/20/2023
- 36-255217
- Exp. 7/23/2023.
Distribution
Distributed nationwide across the United States.
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