Cardioplegia Solution Recalled Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (Induction 4:1 High Potassium) due to lack of sterility assurance following an FDA inspection. The recall affects 84 bags distributed nationwide.
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: This is an FDA Class II recall of an injectable pharmaceutical product with a sterility defect. Although no illnesses or injuries have been reported, the lack of sterility assurance in injectable products used in cardiac surgery poses a significant contamination risk, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Induction 4:1 High Potassium, a sterile injectable solution used in cardiac surgery. The product is packaged in 415 mL bags. The recall affects 84 bags distributed nationwide.
The recall was initiated after an FDA inspection questioned the sterility assurance of the products. Cardioplegia solutions are used to preserve the heart and other organs during cardiac surgery. The inability to assure sterility in injectable products creates a potential contamination risk.
The affected lots are: Lot #37-894307 (Exp 04/29/2023), Lot #37-896158 (Exp 05/06/2023), Lot #37-898281 (Exp 05/14/2023), and Lot #37-900321 (Exp 05/22/2023). The product was distributed nationwide.
Healthcare facilities that received this product should discontinue use and contact the manufacturer for further guidance. Patients and caregivers should not attempt to use the product.
The recalled product
- Product
- Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0106-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-defect
- contamination-risk
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 # 37-894307
- Exp 04/29/2023
- 37-896158
- Exp 05/06/2023
- 37-898281
- Exp 05/14/2023
- 37-900321
- Exp 05/22/2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27