Agency classClass IIOur severity:High FDA (Drugs)·D-0669-2023·Announced 2023-05-31

Cardioplegia Solution Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services recalls Cardioplegia Solution (182 bags, nationwide distribution) due to lack of sterility assurance identified during FDA inspection.

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 FDA Class II recall addresses lack of sterility assurance, which is a theoretical hazard with no confirmed contamination or reported illnesses. Per the rubric, recalls with theoretical hazards and no reported harm score at most 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Modified St Thomas Solution (low potassium, high sodium bicarbonate, 62 mEq K) distributed in 1000 mL bags. The recall affects 182 bags with the following lot numbers: 37-894704 (expires 04/30/2023), 37-896126 (expires 05/06/2023), 37-898276 (expires 05/14/2023), and 37-899141 (expires 05/19/2023). The product was distributed nationwide.

The product is being recalled due to lack of assurance of sterility. During an FDA inspection, questions were raised about whether the products intended to be sterile actually met required sterility standards.

Hospitals and healthcare facilities that received this product should not use it and should contact the manufacturer for further instructions. Patients with questions about this recall or their cardiac procedure should consult their healthcare provider.

The recalled product

Product: Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable Cardiac
Hazard: sterility-assurance
contamination-risk
Affected units: 182

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 # 37-894704
Exp 04/30/2023
37-896126
Exp 05/06/2023
37-898276
Exp 05/14/2023
37-899141
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 →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · sterility assurance