FDAClass IIJuly 12, 2017

Chlorhexidine Gluconate 0.12% Oral Rinse recall: CGMP Deviations

Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16

Why was Chlorhexidine Gluconate 0.12% Oral Rinse recalled?

CGMP Deviations

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?

1999CHG16MC-Lot number 704-201 (full lot # 704-1999-201), Exp 03/20 1999CHG16MC-Lot number 705-208 (full lot # 705-1999-208), Exp 04/20

Product
Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16
Recalling firm
Xttrium Laboratories Inc
Quantity
36,720 16 oz. glass bottles
Distribution
Natiowide
Recall date
July 12, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls