The Recall Desk
HighFDA (Drugs)·D-1039-2023·Announced 2023-08-09

Cardioplegia Solution Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot 36-254906) due to lack of assurance of sterility and missing validation data for decontamination cycles.

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 FDA Class II recall involves a risk-of-harm product (sterile IV solution used in cardiac surgery) with documented manufacturing deficiencies. No illnesses or injuries are reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 84 bags of Cardioplegia Solution (Lot 36-254906, expiring July 22, 2023) distributed nationwide in the United States. This intravenous solution is used during cardiac surgery to protect the heart during the procedure.

The FDA determined that the recalled product lacks assurance of sterility. The manufacturer's validation data for decontamination cycles is incomplete, which raises concerns about whether the product has been properly sterilized.

Healthcare providers who received this product should immediately stop using any bags from the recalled lot and verify they are not in patient care. Patients who received this product should contact their healthcare provider if they develop signs of infection, such as fever, chills, or other unusual symptoms following their procedure.

The recalled product

Product
CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0108-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Intravenous Solution
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 (2)

  • Lot: 36-254906
  • Exp. 7/22/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category