Cardioplegia Solution IV Bags Recalled Due to Sterility Assurance
Central Admixture Pharmacy Services is recalling 72 bags of Cardioplegia Solution due to insufficient validation data for product sterilization processes.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 parenteral medication with unvalidated sterilization processes. No illnesses or confirmed contamination have been reported, but the potential hazard is significant for an intravenous product administered directly into the bloodstream.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag (500 mL). The recalled product is Lot 36-251334 with expiration date 7/13/2023 (NDC: 72196-0105-1), with 72 bags distributed nationwide in the USA.
The recall was issued due to lack of assurance of product sterility. Validation data for decontamination cycles is lacking, which cannot be verified to meet standards for a parenteral (IV) medication.
Healthcare facilities that received this product should contact Central Admixture Pharmacy Services, Inc. (2200 South 43rd Avenue, Phoenix, AZ 85043) or the FDA for further instructions regarding the recalled lot.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 72
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 (2)
- Lot: 36-251334
- Exp. 7/13/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 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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