The Recall Desk
HighFDA (Drugs)·D-0655-2023·Announced 2023-05-31

Cardioplegia Solution Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of assured sterility following an FDA inspection. The product poses a potential infection risk to surgical patients.

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 recall of a sterile pharmaceutical product used in cardiac surgery. While no illnesses or injuries have been reported, the lack of assured sterility constitutes a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine (40 mEq K), distributed nationwide in the United States. The affected lot number is 37-897075 with an expiration date of May 11, 2023, and was packaged in 500 mL bags.

The recall was initiated after an FDA inspection questioned the sterility of the product. Cardioplegia solutions are sterile pharmaceutical products used during cardiac surgery to preserve heart tissue during cardioplegic arrest.

No illnesses or injuries have been reported in connection with this product. Lack of assured sterility could expose surgical patients to serious bacterial infections. Healthcare facilities that received the affected product should quarantine it immediately and contact Central Admixture Pharmacy Services or the FDA for guidance on proper disposition.

The recalled product

Product
Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Injectable / Cardiac Surgery
Hazard
  • lack-of-sterility
  • bacterial-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 # 37-897075
  • Exp 05/11/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category