FDAClass IIAugust 9, 2023

Cardioplegia Solution recall: Sterility Concern

CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc.…

Why was Cardioplegia Solution 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: 36-251643, Exp. 7/13/2023

Product
CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc.…
Recalling firm
Central Admixture Pharmacy Services, Inc.
Quantity
48
Distribution
Nationwide in the USA
Recall date
August 9, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls