The Recall Desk
HighFDA (Drugs)·D-1109-2023·Announced 2023-09-06

Cardioplegia Solution Recalled Due to Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot #36-262515) due to lack of validation data for sanitization cycles, creating uncertainty about sterility standards for this injectable product.

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 an injectable product with serious potential hazard (sterility assurance failure). No reported illnesses or injuries are mentioned in the source. Per the rubric, this constitutes a 'High' severity (Score 3) as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 84 bags of Cardioplegia Solution, High K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, in EVA bags totaling 500 mL each. The affected lot is #36-262515 with expiration date August 25, 2023. The product was distributed nationwide in the USA.

The recall was issued due to lack of assurance of sterility. Specifically, the manufacturer lacked adequate validation data for sanitization cycles, meaning the sterilization/sanitization process was not properly validated. This creates uncertainty about whether the product meets required sterility standards for injectable products.

Healthcare facilities that have received this product should discontinue use immediately and contact the manufacturer or the FDA for further instructions. Patients who may have received this product should consult with their healthcare provider if they have concerns about potential exposure.

The recalled product

Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable / Cardiac Surgery
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 (2)

  • Lot# 36-262515
  • Exp 8/25/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category