The Recall Desk
HighFDA (Drugs)·D-1018-2023·Announced 2023-08-09

FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling Cardioplegia Solution (High K) IV bags due to lack of sterility assurance from insufficient validation of decontamination processes.

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 a FDA Class II recall for lack of sterility assurance in an intravenous medication. The hazard involves manufacturing sterilization validation failure, which could result in non-sterile product being administered. However, the source does not report any illnesses, injuries, or hospitalizations. Per the rubric, recalls with theoretical hazards and no reported illness are scored at a maximum of 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, High K, Induction (4:1 Plasmalyte) IV bags with a total volume of 542 mL per unit. The recall affects 192 units that were distributed nationwide.

The recall was issued due to lack of assurance of sterility. Validation data for decontamination cycles is lacking, which means the sterilization procedures used in manufacturing cannot be adequately verified.

Healthcare facilities and providers who have received this product should stop using it immediately. The affected lot numbers are 36-253953 (expiration 7/20/2023) and 36-255639 (expiration 7/24/2023).

Facilities should contact Central Admixture Pharmacy Services for further information and instructions regarding returned units. Do not dispense or use any units from the recalled lots.

The recalled product

Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total volume = 542 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0212-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Intravenous / Sterile Injectable
Hazard
  • sterility-failure
  • sterilization-validation

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: 36-253953
  • Exp. 7/20/2023
  • 36-255639
  • Exp. 7/24/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category