The Recall Desk
HighFDA (Drugs)·D-0659-2023·Announced 2023-05-31

Cardioplegia Solution Recalled Due to Sterility Assurance Concerns

Cardioplegia Solution is recalled due to sterility assurance concerns identified during an FDA inspection. The recall affects 350 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 deaths. The hazard is theoretical—sterility concerns raised during FDA inspection—without confirmed contamination or patient harm reported. This qualifies as a risk-of-harm product without reported injury, scoring 3 (High) per the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Induction 4:1 (HIGH POTASSIUM/low tromethamine, 36 mEq K), packaged in 500 mL bags. The product is a sterile pharmaceutical.

The recall was initiated following an FDA inspection that called into question whether the product meets sterility requirements. These products are intended to be sterile, and lack of sterility assurance presents a risk to patient safety.

The recall affects 350 bags distributed nationwide. The affected lot numbers are 37-895647 (expiry 05/05/2023), 37-898310 (expiry 05/14/2023), 37-899622 (expiry 05/20/2023), and 37-900951 (expiry 05/26/2023).

For additional information or concerns regarding this product, healthcare providers and facilities should contact Central Admixture Pharmacy Services, Inc. at their facility located in Allentown, Pennsylvania.

The recalled product

Product
Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-0101-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Compounded Drug
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 # 37-895647
  • Exp 05/05/2023
  • 37-898310
  • Exp 05/14/2023
  • 37-899622
  • Exp 05/20/2023
  • 37-900951
  • Exp 05/26/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category