The Recall Desk
HighFDA (Drugs)·D-1108-2023·Announced 2023-09-06

FDA Recalls Cardioplegia Solution Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 184 units of Cardioplegia Solution nationwide due to lack of validation data for sterilization cycles, which compromises sterility assurance in this injectable cardiac medication.

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 sterility assurance defect in an injectable cardiac medication. While the quality defect is serious and poses risk of serious harm to patients, no illnesses or hospitalizations have been reported in the source material.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 184 units of Cardioplegia Solution, 60 mEq K, Induction 4:1, in 830 mL EVA bags. The recall affects two lot numbers: Lot 36-262513 (expiration 8/25/2023) and Lot 36-262880 (expiration 8/27/2023). The products were distributed nationwide throughout the USA.

The recall was initiated due to lack of assurance of sterility resulting from inadequate validation data for sanitization cycles. This means the manufacturing sterilization processes were not adequately validated to ensure the product is sterile.

Cardioplegia solution is an injectable medication administered during cardiac surgery. When sterilization processes lack validation, there is a risk that the product may not be sterile, which could result in serious infection or other complications if administered to patients.

Healthcare facilities and providers should immediately check their inventory for these lot numbers and discontinue use of any units found. Contact Central Admixture Pharmacy Services, Inc. for information regarding product returns, replacement, or further instructions.

The recalled product

Product
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Cardioplegia Solution
Hazard
  • sterility-failure
  • 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 (4)

  • Lot# 36-262513
  • Exp 8/25/2023
  • 36-262880
  • Exp 8/27/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category