The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0666-2023·Announced 2023-05-31

Cardioplegia Solution Recalled Nationwide for Sterility Assurance Concerns

Central Admixture Pharmacy Services recalls 613 bags of cardioplegia solution nationwide due to FDA inspection concerns about sterility assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 where sterility assurance has been called into question by FDA inspection, representing a risk-of-harm to patients. However, no illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed contamination.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium. The product is a 500 mL sterile injectable solution distributed nationwide.

An FDA inspection called into question the sterility assurance of these products. Lack of adequate sterility assurance means the product may not meet pharmaceutical standards for sterility and safety.

The recall affects 613 bags with the following lot numbers and expiration dates: Lot 37-894299 (Exp 04/29/2023), Lot 37-897051 (Exp 05/11/2023), Lot 37-897368 (Exp 05/12/2023), Lot 37-898794 (Exp 05/18/2023), Lot 37-899614 (Exp 05/20/2023), and Lot 37-900608 (Exp 05/25/2023). The product was distributed nationwide.

Hospitals and healthcare facilities that received this product should check their inventory for affected lot numbers. Anyone with questions about this recall should contact the recalling firm or the FDA.

The recalled product

Product
Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Cardioplegia
Hazard
Affected units
613

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 (12)

  • Lot # 37-894299
  • Exp 04/29/2023
  • 37-897051
  • Exp 05/11/2023
  • 37-897368
  • Exp 05/12/2023
  • 37-898794
  • Exp 05/18/2023
  • 37-899614
  • Exp 05/20/2023
  • 37-900608
  • Exp 05/25/2023

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 →

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