FDAClass ISeptember 3, 2014

LOW Potassium Cardioplegia recall: Sterility Concern

LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Why was LOW Potassium Cardioplegia recalled?

Non Sterility; microbial contamination identified as Aspergillus species

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 # 13-920739-01 through Lot # 13-920739-04 (4 total doses) EXP 21 Jun 2014

Product
LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Recalling firm
Central Admixture Pharmacy Services, Inc.
Quantity
4 doses
Distribution
Michigan and Wisconsin
Recall date
September 3, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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