The Recall Desk
HighFDA (Drugs)·D-0662-2023·Announced 2023-05-31

Cardioplegia Solution Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling Cardioplegia Solution nationwide due to lack of assurance of sterility after an FDA inspection questioned the product's sterility.

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. While no illnesses or injuries have been reported, the lack of sterility assurance poses a risk-of-harm in this high-risk medical application, meeting the criteria for a high-severity recall.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Maintenance 4:1 (low potassium/low tromethamine, 36 mEq K), packaged in 1000 mL bags. This recall affects 476 bags distributed nationwide in the USA.

The product is being recalled due to a lack of assurance of sterility. An FDA inspection called into question the sterility of the product, which is intended to be sterile. This is classified as an FDA Class II recall.

The affected lot numbers and expiration dates are: 37-893850 (Exp 04/28/2023), 37-894947 (Exp 05/01/2023), 37-895695 (Exp 05/05/2023), 37-896484 (Exp 05/07/2023), 37-898314 (Exp 05/14/2023), 37-898811 (Exp 05/18/2023), and 37-900616 (Exp 05/25/2023). The manufacturer is Central Admixture Pharmacy Services, Inc., located at 6580 Snowdrift Road, Lehigh Valley, Allentown, PA 18106.

The recalled product

Product
Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0104-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Pharmaceutical / Cardiac Surgery
Hazard
  • sterility-failure
  • 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 (14)

  • Lot # 37-893850
  • Exp 04/28/2023
  • 37-894947
  • Exp 05/01/2023
  • 37-895695
  • Exp 05/05/2023
  • 37-896484
  • Exp 05/07/2023
  • 37-898314
  • Exp 05/14/2023
  • 37-898811
  • Exp 05/18/2023
  • 37-900616
  • Exp 05/25/2023

Distribution

Distributed nationwide across the United States.

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