Agency classClass IIOur severity:High FDA (Drugs)·D-0676-2023·Announced 2023-05-31

FDA Recalls Cardioplegia Solution Due to Sterility Assurance Issues

Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to FDA concerns about sterility assurance. The recall affects 52 bags 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 a Class II recall with no reported illnesses or injuries. Per the severity rubric, when illnesses or injuries are not reported and the hazard remains theoretical, the maximum score is 3. The High rating reflects the seriousness of sterility assurance in pharmaceutical products, though no contamination or patient harm has been documented.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Induction 4:1 Plasmalyte, packaged in 542 mL bags, due to lack of assurance of sterility. Following an FDA inspection, the agency questioned whether these products maintain the sterility they are intended to have.

The recall affects 52 bags distributed nationwide. The affected lot numbers and expiration dates are: 37-895217 (Exp 05/04/2023), 37-898803 (Exp 05/18/2023), and 37-900614 (Exp 05/25/2023). The product has NDC 71285-0212-1 and is manufactured by Central Admixture Pharmacy Services, Inc., located at 6580 Snowdrift Road, Allentown, PA 18106.

This is a Class II FDA recall. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product: Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0212-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Compounded Pharmaceuticals
Hazard: sterility-failure
contamination-risk
Affected units: 52

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 (6)

Lot # 37-895217
Exp 05/04/2023
37-898803
Exp 05/18/2023
37-900614
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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