The Recall Desk
HighFDA (Drugs)·D-1025-2023·Announced 2023-08-09

Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency

Central Admixture Pharmacy Services recalls Leesburg Cardioplegia Solution due to inadequate sterilization validation. The recall affects 36 bags 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 with no reported illnesses or injuries. The hazard is based on insufficient validation of sterilization processes rather than confirmed contamination. This represents a risk-of-harm product where adverse events have not been reported, meeting the criteria for a High severity rating.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 36 bags of Leesburg Cardioplegia Solution (1030.2 mL IV bags, NDC 72196-0218-1) distributed nationwide. The recall was initiated due to a lack of assurance of sterility and insufficient validation data for decontamination cycles used during product sterilization.

Cardioplegia solution is a specialized intravenous medication administered during cardiac surgery to preserve the heart during the operation. Proper sterilization validation is critical to ensuring patient safety with this injectable product.

Healthcare facilities that received this product should discontinue use of the affected lot (Lot 36-255941, expiration 7/27/2023) immediately and contact their pharmacy supplier. If any units from this lot have been administered, healthcare providers should be alerted and any adverse events reported to the FDA.

For more information, healthcare facilities may contact Central Admixture Pharmacy Services, Inc. directly, or report concerns to the FDA at 1-888-SAFEFOOD or online at www.fda.gov/medwatch.

The recalled product

Product
CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0218-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Solution
Hazard
  • sterility-assurance
  • contamination-risk
  • validation-deficiency

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 (2)

  • Lot:36-255941
  • Exp. 7/27/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category