FDAClass IIOctober 2, 2024

Custodiol HTK Solution recall

Custodiol HTK Solution, 500ml bottle. 10 per carton.

Why was Custodiol HTK Solution recalled?

Potential for particles to be present in solution.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)

Product
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Recalling firm
Dr Franz Koehler Chemie Gmbh
Quantity
48 cartons (480 bottles)
Distribution
US Nationwide distribution in the state of North Carolina.
Recall date
October 2, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls