FDA Recalls Cardioplegia Solution Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution, Reperfusate 4:1 due to lack of sterility assurance identified during an FDA inspection. The recall affects 338 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 recall for lack of sterility assurance in a compounded pharmaceutical product. No illnesses or injuries are reported in the source text; however, a sterile product that cannot be assured to meet sterility requirements poses a significant safety risk to patients.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Reperfusate 4:1 low potassium (15 mEq K), packaged in 477.5 mL bags. This solution is used in cardiac surgery to perfuse and protect the heart during surgical procedures. A total of 338 bags are affected by this recall.
The FDA issued this recall after an inspection raised questions about the sterility of the products intended to be sterile. When a sterile pharmaceutical product cannot be assured to be sterile, it poses a potential risk to patient safety.
The product was distributed nationwide in the United States. The affected lot numbers are 37-893847 (Exp 04/28/2023), 37-895646 (Exp 05/05/2023), 37-897804 (Exp 05/12/2023), and 37-899236 (Exp 05/19/2023). Additional information about this recall is available from Central Admixture Pharmacy Services, Inc., located at 6580 Snowdrift Road, Allentown, PA 18106.
The recalled product
- Product
- Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0008-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 338
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 # 37-893847
- Exp 04/28/2023
- 37-895646
- Exp 05/05/2023
- 37-897804
- Exp 05/12/2023
- 37-899236
- 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.
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