The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0649-2023·Announced 2023-05-31

Cardioplegia Solution recalled due to lack of sterility assurance

Central Admixture Pharmacy Services is recalling its Cardioplegia Solution due to lack of assurance of sterility. An FDA inspection determined that the sterility of these products intended for cardiac surgery could not be assured.

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 of a sterile injectable product where the manufacturer cannot assure sterility. Per the severity rubric, a risk-of-harm product for use in cardiac surgery where injury has not yet been reported receives a score of 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling its Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) in 500 mL bags. The recall affects 215 bags distributed nationwide in the United States, including lot numbers 37-893802 (expires 04/28/2023), 37-894943 (expires 05/01/2023), 37-896487 (expires 05/07/2023), 37-898248 (expires 05/14/2023), and 37-899171 (expires 05/19/2023).

The FDA inspected the manufacturer and called into question the sterility of these products, which are intended to be sterile. The manufacturer is recalling the product due to a lack of assurance of sterility.

Consumers and facilities that have received these products should refer to the product's labeling for further information regarding the recall.

The recalled product

Product
Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0002-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Injectable
Hazard
Affected units
215

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 (10)

  • Lot # 37-893802
  • Exp 04/28/2023
  • 37-894943
  • Exp 05/01/2023
  • 37-896487
  • Exp 05/07/2023
  • 37-898248
  • Exp 05/14/2023
  • 37-899171
  • Exp 05/19/2023

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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