The Recall Desk
HighFDA (Drugs)·D-0661-2023·Announced 2023-05-31

FDA Recalls Cardioplegia Solution for Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling cardioplegia solution due to sterility assurance concerns identified in an FDA inspection. The recall affects 269 bags 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: FDA Class II recall with no reported illnesses or injuries. Per the severity rubric, this qualifies as a risk-of-harm product (sterile injectable for cardiac use) where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc., of Allentown, Pennsylvania, is recalling Cardioplegia Solution, Maintenance 4:1 low potassium formulation (810 mL per bag, NDC 71285-0103-1) due to a lack of assurance of product sterility. An FDA inspection raised concerns about whether the product met sterility requirements.

Cardioplegia solution is a sterile injectable product used during cardiac surgery. The recall affects 269 bags distributed nationwide. The affected lots are: 37-893803 (expires 04/28/2023), 37-896483 (expires 05/07/2023), 37-897939 (expires 05/13/2023), and 37-900952 (expires 05/26/2023).

Healthcare providers who have this product should contact Central Admixture Pharmacy Services, Inc., for guidance regarding the recalled product.

The recalled product

Product
Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0103-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Pharmaceutical
Hazard
Affected units
269

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 # 37-893803
  • Exp 04/28/2023
  • 37-896483
  • Exp 05/07/2023
  • 37-897939
  • Exp 05/13/2023
  • 37-900952
  • Exp 05/26/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 108 products in this recall →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · sterility failure

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