The Recall Desk
HighFDA (Drugs)·D-0669-2023·Announced 2023-05-31

Cardioplegia Solution Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services recalls Cardioplegia Solution (182 bags, nationwide distribution) due to lack of sterility assurance identified during FDA inspection.

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 FDA Class II recall addresses lack of sterility assurance, which is a theoretical hazard with no confirmed contamination or reported illnesses. Per the rubric, recalls with theoretical hazards and no reported harm score at most 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Modified St Thomas Solution (low potassium, high sodium bicarbonate, 62 mEq K) distributed in 1000 mL bags. The recall affects 182 bags with the following lot numbers: 37-894704 (expires 04/30/2023), 37-896126 (expires 05/06/2023), 37-898276 (expires 05/14/2023), and 37-899141 (expires 05/19/2023). The product was distributed nationwide.

The product is being recalled due to lack of assurance of sterility. During an FDA inspection, questions were raised about whether the products intended to be sterile actually met required sterility standards.

Hospitals and healthcare facilities that received this product should not use it and should contact the manufacturer for further instructions. Patients with questions about this recall or their cardiac procedure should consult their healthcare provider.

The recalled product

Product
Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Cardiac
Hazard
  • sterility-assurance
  • 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 (8)

  • Lot # 37-894704
  • Exp 04/30/2023
  • 37-896126
  • Exp 05/06/2023
  • 37-898276
  • Exp 05/14/2023
  • 37-899141
  • Exp 05/19/2023

Distribution

Distributed nationwide across the United States.

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