Xttrium Chlorhexidine Rinse Recall: CGMP Deviations in 1999CHG16MC Lot Numbers
Xttrium Laboratories recalls 0.12% Chlorhexidine Gluconate oral rinse due to CGMP deviations. Affected lots 704-201 (exp 03/20) and 705-208 (exp 04/20) were distributed in 1999. No remedy specified in recall notice.
Recall notice
CGMP Deviations
Contact the company
What happened, in plain English
Xttrium Laboratories is recalling a specific 0.12% Chlorhexidine Gluconate oral rinse product due to manufacturing quality control issues. This recall affects certain lot numbers from 1999 that may have been distributed through their company. The issue does not involve immediate safety risks but requires consumers to check their product details. Read more at govinfonow.com/recall/41589-xttrium-chlorhexidine-rinse-recall-cgmp-deviations-in-1999chg16mc-lot-numbers.
Source Summary by GovInfoNow · govinfonow.com/recall/41589-xttrium-chlorhexidine-rinse-recall-cgmp-deviations-in-1999chg16mc-lot-numbers · Updated October 8, 2026 · FDA enforcement record: FDA #D-0938-2017
Cite this page
“Xttrium Chlorhexidine Rinse Recall: CGMP Deviations in 1999CHG16MC Lot Numbers.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41589-xttrium-chlorhexidine-rinse-recall-cgmp-deviations-in-1999chg16mc-lot-numbers. Based on FDA recall #D-0938-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0938-2017%22&limit=1).
Why it’s dangerous
The recall is due to CGMP (Current Good Manufacturing Practice) deviations, which are regulatory standards for ensuring product quality and safety. These deviations indicate potential issues in the manufacturing process that could affect the product's safety and effectiveness.
Who’s affected
People who purchased the 0.12% Chlorhexidine Gluconate oral rinse from Xttrium Laboratories in 1999 are likely affected. Those with the specific lot numbers 704-201 or 705-208 are at risk of receiving a product with manufacturing deviations.
How to tell if you have this one
Check the product label for the lot number 704-201 (expiring 03/20) or 705-208 (expiring 04/20). The product is a 1 pint (473 ml) oral rinse sold by Xttrium Laboratories, Inc. in 1999.
- Brand
Xttrium Laboratories- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number on the label to determine if your product is affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0938-2017 (June 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0938-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.