Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling its Cardioplegia Solution, del Nido Formula, nationwide after an FDA inspection questioned the product's sterility.
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: FDA Class II recall of a sterile pharmaceutical product where FDA inspection questioned sterility assurance. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, which per the rubric merits Score 3.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, del Nido Formula (NDC 71285-0202-1), packaged in 1,052.8 mL bags. Approximately 12,888 bags have been distributed nationwide in the USA.
The recall was initiated after an FDA inspection called into question the sterility assurance of the products. Cardioplegia solution is used during cardiac surgery to preserve the heart during the surgical procedure. Affected lot numbers span from 37-890033 through 37-900316 with expiration dates between April 28, 2023 and June 6, 2023.
Healthcare facilities that have received affected lots should stop using the product immediately. No illnesses or injuries have been reported. For more information or to return affected product, contact the manufacturer at Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Road, Allentown, PA 18106.
The recalled product
- Product
- Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0202-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Sterile Injectable
- Hazard
- sterility-failure
- 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 (20)
- Lot # 37-890033
- 37-890035
- Exp 04/28/2023
- 37-890518
- 37-890527
- 37-890536
- 37-890538
- Exp 04/29/2023
- 37-890844
- 37-890845
- Exp 04/30/2023
- 37-891159
- 37-891161
- 37-891187
- 37-891190
- 37-891212
- 37-891213
- 37-891222
- 37-891223
- Exp 05/01/2023
Distribution
Distributed nationwide across the United States.
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