The Recall Desk
HighFDA (Drugs)·D-1032-2023·Announced 2023-08-09

Cardioplegia Solution Recalled Due to Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of sterility assurance and missing validation data for manufacturing 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 is an FDA Class II drug recall for a sterile injectable product used in cardiac surgery with significant potential for harm if contaminated. No illnesses, injuries, or deaths have been reported. Per the rubric, recalls without reported illness and with theoretical hazard risk score at most 3.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, in 500 mL IV bags. This product is used during cardiac surgical procedures.

The recall was initiated because the company lacks assurance of sterility. Validation data for decontamination cycles is lacking, which prevents verification that the manufacturing process adequately removes microorganisms from the product.

Lot 36-255940, with an expiration date of July 27, 2023, was affected. Fifty-six bags were distributed nationwide in the United States.

The recalled product

Product
CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0102-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Pharmaceutical
Hazard
  • sterility
  • contamination

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: 36-255940
  • Exp. 7/27/2023

Distribution

Distributed nationwide across the United States.

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