Cardioplegia Solution Recalled Due to Inadequate Sterility Assurance
Central Admixture Pharmacy Services is recalling cardioplegia solution IV bags nationwide due to lack of validated sterilization processes. The recall affects 184 bags from two lots.
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 demonstrated sterilization process validation deficiency. No reported illnesses, injuries, or confirmed contamination. The hazard is theoretical based on process control failure rather than confirmed microbial contamination, meeting the criterion for High: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling cardioplegia solution IV bags (low K maintenance, 4:1 Plasmalyte/Tromethamine, 1000 mL per bag) due to deficiency in sterilization assurance. The recall is based on a finding that validation data for the manufacturer's decontamination cycles is lacking, meaning the company cannot confirm the product meets required sterility standards.
The recalled product consists of 184 IV bags distributed nationwide. The affected lots are: Lot 36-251456 (expiration 7/14/2023) and Lot 36-256020 (expiration 7/28/2023). The product is manufactured by Central Admixture Pharmacy Services, Inc., Phoenix, Arizona (NDC: 72196-0112-1).
Healthcare facilities that received this product should discontinue use and contact the manufacturer for instructions on return or replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0112-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-assurance
- validation-deficiency
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: 36-251456
- Exp. 7/14/2023
- 36-256020
- Exp. 7/28/2023.
Distribution
Distributed nationwide across the United States.
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