Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services, Inc. is recalling 48 bags of Cardioplegia Solution after an FDA inspection found the manufacturer could not assure the product's sterility. The product was 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 with no reported illnesses or injuries. The product is a risk-of-harm item (sterile injectable medication) where injury has not yet been reported, consistent with the High severity category per the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Induction 8:1 High Potassium/Low Dextrose (100 mEq K, 500 mL per bag) with NDC 71285-0107-1. The recall involves 48 bags from two lots: Lot # 37-897926 (Expiration 05/13/2023) and Lot # 37-900464 (Expiration 05/22/2023).
The FDA recalled the product after an inspection called into question the sterility of the product. Cardioplegia solution is an injectable medication used in cardiac surgery to stop the heart during the procedure. Without proper assurance of sterility, the product poses a contamination risk.
The product was distributed nationwide in the United States to hospitals and healthcare facilities.
Healthcare providers should not use these lots.
The recalled product
- Product
- Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0107-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Cardioplegia Solution
- Hazard
- Affected units
- 48
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 (4)
- Lot # 37-897926
- Exp 05/13/2023
- 37-900464
- Exp 05/22/2023
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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