Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution (Maintenance 4:1 in Ringer's) due to lack of sterility assurance confirmed by FDA inspection. The product is used during cardiac surgery and 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: This is an FDA Class II recall of a sterile injectable product used in cardiac surgery. The lack of sterility assurance confirmed by FDA inspection poses a significant risk, but no illnesses or injuries have been reported, qualifying it as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium (12 mEq K), packaged in 504.8 mL bags. This prescription medication is used in cardiac surgery to protect the heart during cardiopulmonary bypass. A total of 280 bags have been distributed nationwide.
The FDA conducted an inspection that called into question the sterility assurance of the product. Because cardioplegia solution is administered directly into the body during surgery, it must be sterile. The lack of confirmed sterility assurance poses a potential risk of serious infection.
The affected lot numbers are 37-894325 (expiring 04/29/2023), 37-895211 (expiring 05/04/2023), and 37-899265 (expiring 05/19/2023). Healthcare providers should immediately discontinue use of affected lots. Patients who received this product should contact their healthcare provider if they experience any unexpected health changes.
The recalled product
- Product
- Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0205-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous Solution
- Affected units
- 280
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 (6)
- Lot # 37-894325
- Exp 04/29/2023
- 37-895211
- Exp 05/04/2023
- 37-899265
- Exp 05/19/2023
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 · contamination
See all →- SevereEthicon Recalls Silk Surgical Sutures Packaged with Alcohol-Based Fluid
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateAVID Medical Recalls Urology Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighCardioplegia Solution Recalled Due to Insufficient Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighCardioplegia solution IV bags 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 Concerns
FDA (Drugs) · 2023-08-09