Agency classClass IIOur severity:High FDA (Drugs)·D-1024-2023·Announced 2023-08-09

Cardioplegia solution IV bags recalled for lack of sterility assurance

Central Admixture Pharmacy Services is recalling 308 bags of cardioplegia solution nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles.

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 a Class II recall involving a sterility assurance issue in an injectable pharmaceutical product. No illnesses, injuries, or hospitalizations have been reported, and the hazard is potential rather than confirmed. This represents a risk-of-harm product where injury has not yet been reported, warranting a High severity score.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 308 bags of cardioplegia solution distributed nationwide. The product is supplied as an IV bag with a total volume of 522.8 mL (NDC: 72196-0206-1).

The recall is due to lack of assurance of sterility and insufficient validation data for decontamination cycles used in the manufacturing process. The U.S. Food and Drug Administration classified this as a Class II recall. The affected lots are: Lot 36-253951 (expires 7/20/2023), 36-254912 (expires 7/22/2023), 36-255215 (expires 7/23/2023), and 36-255216 (expires 7/23/2023).

Healthcare facilities that received this product should contact Central Admixture Pharmacy Services for instructions. Patients who may have received this product should consult their healthcare provider with any concerns.

The recalled product

Product: CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total volume = 522.8 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0206-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable Solution
Hazard: lack-of-sterility
contamination-risk
Affected units: 308

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 (7)

Lot: 36-253951
Exp. 7/20/2023
36-254912
Exp. 7/22/2023
36-255215
36-255216
Exp. 7/23/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 95 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 95 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

See all →

Moderate
Pediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
Severe
Pediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
Severe
Injectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
High
Ephedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
High
Fentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11

Same hazard · lack of sterility