The Recall Desk
HighFDA (Drugs)·D-0671-2023·Announced 2023-05-31

Cardioplegia Solution Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services recalls Cardioplegia Solution (Maintenance 4:1 in Ringer's) due to lack of sterility assurance confirmed by FDA inspection. The product is used during cardiac surgery and distributed nationwide.

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 injectable product used in cardiac surgery. The lack of sterility assurance confirmed by FDA inspection poses a significant risk, but no illnesses or injuries have been reported, qualifying it as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium (12 mEq K), packaged in 504.8 mL bags. This prescription medication is used in cardiac surgery to protect the heart during cardiopulmonary bypass. A total of 280 bags have been distributed nationwide.

The FDA conducted an inspection that called into question the sterility assurance of the product. Because cardioplegia solution is administered directly into the body during surgery, it must be sterile. The lack of confirmed sterility assurance poses a potential risk of serious infection.

The affected lot numbers are 37-894325 (expiring 04/29/2023), 37-895211 (expiring 05/04/2023), and 37-899265 (expiring 05/19/2023). Healthcare providers should immediately discontinue use of affected lots. Patients who received this product should contact their healthcare provider if they experience any unexpected health changes.

The recalled product

Product
Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0205-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Intravenous Solution
Hazard
  • contamination
  • infection-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 (6)

  • Lot # 37-894325
  • Exp 04/29/2023
  • 37-895211
  • Exp 05/04/2023
  • 37-899265
  • Exp 05/19/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category