Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services recalls Cardioplegia Solution (Lot 36-253947) due to lack of sterility assurance and insufficient decontamination validation. Healthcare facilities should discontinue use and contact the manufacturer.
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 sterile injectable due to unverified sterilization processes with lack of sterility assurance. No reported illnesses, injuries, or deaths. Classified as High because it involves a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag (NDC 72196-0217-1) distributed nationwide in the USA. The recalled product includes Lot 36-253947, which expires 7/20/2023. A total of 44 bags have been identified in this recall.
The recall was initiated due to lack of assurance of sterility and insufficient validation data for decontamination cycles. This means the sterilization process used for this product cannot be verified as adequate, creating a potential risk of microbial contamination in this sterile injectable solution.
Healthcare facilities that received this product should immediately discontinue use of the affected lot and secure it appropriately. Facilities should consult with Central Admixture Pharmacy Services, Inc. regarding proper disposal procedures and determine whether patient notification is necessary based on product exposure and individual clinical status.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Sterile Injectable
- Affected units
- 44
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:36-253947
- Exp. 7/20/2023.
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.
See all 95 products in this recall →Related recalls
Same manufacturer · Central Admixture Pharmacy Services, Inc.
See all →- ModeratePediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
- SeverePediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
- SevereInjectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
- HighEphedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighFentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighCardioplegia Solution Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-09-06
- HighFDA Recalls Cardioplegia Solution Due to Sterility Assurance Failure
FDA (Drugs) · 2023-09-06
- HighFDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-09-06
- HighCardioplegia Solution Recalled for Unvalidated Sterilization Process
FDA (Drugs) · 2023-09-06
- HighFDA Recalls Cardioplegia Solution Due to Sterility Assurance Defect
FDA (Drugs) · 2023-05-31
- HighCardioplegia Solution Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-05-31