Agency classClass IIOur severity:High FDA (Drugs)·D-0650-2023·Announced 2023-05-31

Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 255 bags of Cardioplegia Solution after FDA inspection questioned its sterility assurance. The product was distributed nationwide.

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 involving loss of sterility assurance for a sterile injectable product. No illnesses or injuries have been reported. Per the severity rubric, when no harm is reported and the hazard is theoretical, the maximum score is High (3).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag. The recall affects 255 bags distributed nationwide in the USA.

The recall was issued after an FDA inspection raised concerns about the sterility assurance of the product. Products intended for sterile use must be manufactured and handled according to strict quality standards to prevent contamination that could result in patient harm.

Affected lot numbers are: 37-893790 (Exp 04/28/2023), 37-896488 (Exp 05/07/2023), 37-898250 (Exp 05/14/2023), 37-899235 (Exp 05/19/2023), and 37-900609 (Exp 05/25/2023). Healthcare facilities that have received this product should stop using the affected lots and contact Central Admixture Pharmacy Services for recall instructions.

The recalled product

Product: Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0005-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Compounded Sterile Injectable
Hazard: sterility
contamination
Affected units: 255

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 # 37-893790
Exp 04/28/2023
37-896488
Exp 05/07/2023
37-898250
Exp 05/14/2023
37-899235
Exp 05/19/2023
37-900609
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 →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · sterility