Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls Cardioplegia Solution (325 bags nationwide) after FDA inspection identified loss of sterility assurance. Product is used in cardiac surgery and requires prescription.
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 for a sterile injectable product used in critical cardiac surgery where loss of sterility assurance poses serious potential harm. No illnesses have been reported, placing this in the risk-of-harm category per the severity rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, a sterile injectable drug used during cardiac surgery. The product is formulated as a Maintenance 8:1 non-enriched solution with 24 mEq K, packaged in 300 mL bags (NDC 71285-0215-1). An FDA inspection identified a lack of assurance of sterility, meaning the manufacturer could not adequately demonstrate that these products were manufactured and maintained under proper sterile conditions.
The recall affects 325 bags distributed nationwide across the United States. Affected lot numbers are 37-895694 and 37-896050 (expiring May 5, 2023), 37-898304 (expiring May 14, 2023), 37-899234 (expiring May 19, 2023), and 37-901375 (expiring May 27, 2023). The product is available only by prescription.
Healthcare facilities and medical professionals should immediately discontinue use of affected lot numbers. Contact Central Admixture Pharmacy Services, Inc. in Allentown, Pennsylvania for instructions on return or destruction of recalled product. Patients who have received this product during cardiac surgery should contact their healthcare provider with any questions or concerns.
The recalled product
- Product
- Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Sterile Injectable
- Affected units
- 325
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 (9)
- Lot # 37-895694
- 37-896050
- Exp 05/05/2023
- 37-898304
- Exp 05/14/2023
- 37-899234
- Exp 05/19/2023
- 37-901375
- 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.
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