FDAClass IIIAugust 23, 2017

Chlorhexidine Gluconate Oral Rinse recall: Subpotent

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only…

Why was Chlorhexidine Gluconate Oral Rinse recalled?

Crystallization with subpotent out of specification assay results for chlorhexidine.

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: 353394, Exp 10-2018

Product
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only…
Recalling firm
Akorn Inc
Quantity
541,900 unit dose cups (5,419 trays)
Distribution
Nationwide in the USA
Recall date
August 23, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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