Cardioplegia solution IV bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 308 bags of cardioplegia solution nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles.
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 a Class II recall involving a sterility assurance issue in an injectable pharmaceutical product. No illnesses, injuries, or hospitalizations have been reported, and the hazard is potential rather than confirmed. This represents a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 308 bags of cardioplegia solution distributed nationwide. The product is supplied as an IV bag with a total volume of 522.8 mL (NDC: 72196-0206-1).
The recall is due to lack of assurance of sterility and insufficient validation data for decontamination cycles used in the manufacturing process. The U.S. Food and Drug Administration classified this as a Class II recall. The affected lots are: Lot 36-253951 (expires 7/20/2023), 36-254912 (expires 7/22/2023), 36-255215 (expires 7/23/2023), and 36-255216 (expires 7/23/2023).
Healthcare facilities that received this product should contact Central Admixture Pharmacy Services for instructions. Patients who may have received this product should consult their healthcare provider with any concerns.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total volume = 522.8 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0206-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Solution
- Hazard
- lack-of-sterility
- 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 (7)
- Lot: 36-253951
- Exp. 7/20/2023
- 36-254912
- Exp. 7/22/2023
- 36-255215
- 36-255216
- Exp. 7/23/2023
Distribution
Distributed nationwide across the United States.
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