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.
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 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
- Affected units
- 12,888
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.
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.
See all 108 products in this recall →Related recalls
Same manufacturer · Central Admixture Pharmacy Services, Inc.
See all →- ModeratePediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
- SeverePediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
- SevereInjectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
- HighEphedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighFentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighCardioplegia Solution Recalled for Lack of Sterility Validation
FDA (Drugs) · 2023-09-06
- HighCardioplegia Solution del Nido Formula Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Recalled Due to Sterility Assurance Deficiency
FDA (Drugs) · 2023-08-09