Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 255 bags of Cardioplegia Solution after FDA inspection questioned its sterility assurance. The product was 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 involving loss of sterility assurance for a sterile injectable product. No illnesses or injuries have been reported. Per the severity rubric, when no harm is reported and the hazard is theoretical, the maximum score is High (3).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag. The recall affects 255 bags distributed nationwide in the USA.
The recall was issued after an FDA inspection raised concerns about the sterility assurance of the product. Products intended for sterile use must be manufactured and handled according to strict quality standards to prevent contamination that could result in patient harm.
Affected lot numbers are: 37-893790 (Exp 04/28/2023), 37-896488 (Exp 05/07/2023), 37-898250 (Exp 05/14/2023), 37-899235 (Exp 05/19/2023), and 37-900609 (Exp 05/25/2023). Healthcare facilities that have received this product should stop using the affected lots and contact Central Admixture Pharmacy Services for recall instructions.
The recalled product
- Product
- Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0005-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility
- contamination
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 (10)
- Lot # 37-893790
- Exp 04/28/2023
- 37-896488
- Exp 05/07/2023
- 37-898250
- Exp 05/14/2023
- 37-899235
- Exp 05/19/2023
- 37-900609
- Exp 05/25/2023
Distribution
Distributed nationwide across the United States.
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