Cardioplegia Solution Recalled Nationwide Due to Unverified Sterility
Central Admixture Pharmacy Services is recalling 79 bags of Cardioplegia Solution nationwide because an FDA inspection found that the sterility of the product could not be assured.
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 for a sterile injectable product used in critical cardiac surgery where sterility cannot be assured. Although no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where injury has not yet materialized.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Leesburg Cardioplegia Solution (NDC 71285-0218-1), packaged in 1030.2 mL bags, after an FDA inspection found that the manufacturer could not assure the sterility of the product. The affected lots are #37-895256 (expiration 05/04/2023) and #37-898816 (expiration 05/18/2023). A total of 79 bags were distributed nationwide in the USA.
Cardioplegia solution is a sterile injectable medication used during cardiac surgery to protect the heart. Sterile drugs must meet strict manufacturing and quality standards. An inability to assure sterility in an injectable product poses a potential risk to patients, as non-sterile injectables can cause infection or serious complications.
Healthcare facilities and surgical centers that received these specific lots should stop using them immediately. Contact Central Admixture Pharmacy Services, Inc. at their Allentown, PA location for instructions on return or proper disposal. Consult your healthcare provider if you received this product.
The recalled product
- Product
- Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0218-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- lack-of-sterility
- 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 (4)
- Lot # 37-895256
- Exp 05/04/2023
- 37-898816
- Exp 05/18/2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27