FDAClass IIAugust 9, 2023

Cardioplegia Solution 40 Meq K recall: Sterility Concern

CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc.…

Why was Cardioplegia Solution 40 Meq K recalled?

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 36-252143, Exp. 7/16/2023.

Product
CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc.…
Recalling firm
Central Admixture Pharmacy Services, Inc.
Quantity
80 bags
Distribution
Nationwide in the USA
Recall date
August 9, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls