Agency classClass IIOur severity:High FDA (Drugs)·D-1034-2023·Announced 2023-08-09

Cardioplegia IV Solution Recalled Due to Sterility Assurance Deficiency

Central Admixture Pharmacy Services has recalled Cardioplegia Solution due to lacking sterility assurance and insufficient validation data for decontamination cycles. The recall affects 148 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 an FDA Class II recall involving inadequate sterility assurance for a sterile injectable product. No reported illnesses, deaths, or injuries are documented. The score reflects the seriousness of a potential sterility defect in a critical-use injectable without confirmed harm.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, 70 mEq K, Induction 8:1, a high potassium IV solution in 300 mL bags. The product (NDC: 72196-0214-1) was distributed nationwide in the USA. Two lot numbers are affected: Lot 36-253954 (expiration 7/20/2023) and Lot 36-256032 (expiration 7/28/2023). A total of 148 bags are subject to this recall.

The recall was initiated due to lack of assurance of sterility. The manufacturer has not provided adequate validation data for the decontamination cycles used in the sterilization process, raising concerns about whether the product is sterile and safe for use.

This product is an intravenous (IV) solution intended for use in hospital settings. Healthcare facilities, pharmacies, and medical professionals that received the affected lot numbers should be aware of this recall.

Healthcare facilities and medical professionals should immediately quarantine and discontinue use of the affected product lots. Anyone with questions or concerns should contact the FDA or the recalling manufacturer, Central Admixture Pharmacy Services, Inc.

The recalled product

Product: CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0214-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable / Sterile Solution
Hazard: lack-of-sterility
contamination-risk
Affected units: 148

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 (4)

Lot: 36-253954
Exp. 7/20/2023
36-256032
Exp. 7/28/2023

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.

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