Reported Jul 12, 2017 · Terminated

Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc.,…

Xttrium Laboratories Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Xttrium Laboratories Inc · 415 W Pershing Rd · Chicago, IL · 60609-2788

Is this the product you have?

  • Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only
  • Distributed byXttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16
Lot codes and dates
  • 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
Amount recalled
36,720 16 oz. glass bottles

Why it was recalled

CGMP Deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 19, 2018 · Data as of Sep 19, 7:20 PM UTC

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