The Recall Desk
HighFDA (Drugs)·D-1041-2023·Announced 2023-08-09

FDA Recalls Cardioplegia Solution for Lacking Sterility Validation Data

Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products 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 due to inadequate validation of sterilization processes for an intravenous cardiac solution. The lack of sterility assurance in a critical-care injectable product creates a significant risk of pathogenic contamination. This risk-of-harm scenario, absent reported illnesses, merits a High severity rating per the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling a cardioplegia solution used during open-heart surgery. The product is a 300 mL intravenous (IV) bag of Cardioplegia Solution containing 24 mEq potassium (K) in an 8:1 formulation, requiring a prescription. The recall affects 104 bags distributed nationwide in the United States.

The recall was issued because the manufacturer lacks sufficient validation data for sterilization decontamination cycles. Without documented validation, there is no assurance that the solution is sterile before use. A contaminated sterile IV solution used directly in cardiac surgery could introduce pathogens into the bloodstream, creating a risk of infection during or after the procedure.

Two lot numbers are affected: Lot 36-254125 (expiring July 20, 2023) and Lot 36-256034 (expiring July 28, 2023). The product is identified by NDC 72196-0215-1 and was manufactured by Central Admixture Pharmacy Services, Inc., located in Phoenix, Arizona.

Healthcare facilities and hospitals that received this product should immediately cease use and quarantine affected inventory. Contact the manufacturer or the FDA for information regarding verification, replacement, or refunds.

The recalled product

Product
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Cardiac Surgical Solutions
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: 36-254125
  • Exp. 7/20/2023
  • 36-256034
  • Exp. 7/28/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category