FDAClass IIJune 13, 2018

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate recall: Labeling Error

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be…

Why was NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate recalled?

The bottles are mislabeled with an incorrect part number.

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 Code: 18CXAC095

Product
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be…
Recalling firm
Fresenius Medical Care Renal Therapies Group, LLC
Quantity
1060 cases (4240 bottles)
Distribution
Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.
Recall date
June 13, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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