FDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance. An FDA inspection questioned sterility of 254 bags distributed nationwide.
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 sterility assurance recall affecting an injectable pharmaceutical with no reported illnesses or injuries. While lack of sterility assurance in a cardiac surgical drug presents significant patient safety risk, the actual hazard is theoretical.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Reperfusate 4:1 (NDC 71285-0009-1) due to lack of assurance of sterility. An FDA inspection called into question whether the product met sterility requirements for its intended use.
Four affected lots totaling 254 bags have been distributed nationwide: Lot 37-893848 (expires 04/28/2023), Lot 37-895681 (expires 05/05/2023), Lot 37-899250 (expires 05/19/2023), and Lot 37-901355 (expires 05/27/2023). The manufacturer is Central Admixture Pharmacy Services, Inc., located in Allentown, Pennsylvania.
Microbial contamination of a sterile injectable pharmaceutical could pose serious risks to patient health. No illnesses or injuries related to this recall have been reported.
Healthcare providers and patients using the affected lots should discontinue use immediately and contact the manufacturer or FDA for instructions regarding product return or disposal.
The recalled product
- Product
- Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug
- Affected units
- 254
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 (8)
- Lot # 37-893848
- Exp 04/28/2023
- 37-895681
- Exp 05/05/2023
- 37-899250
- Exp 05/19/2023
- 37-901355
- Exp 05/27/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 108 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 108 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 · sterility assurance
See all →- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
Similar recalls
- HighCardioplegia Solution recalled for lack of sterility assurance
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-08-09
- HighFDA Recalls Cardioplegia Solution for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution IV bags recalled for missing sterility validation
FDA (Drugs) · 2023-08-09