Xttrium Laboratories, Inc.
NDC labeler code: 0116
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Chlorhexidine gluconatePeriogard Alcohol Free, Dash Chlorhexidine Gluconate 0.12% Oral Rinse, Chlorhexidine Gluconate 0.12% Oral Rinse · 12 products
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 2 products
- Promethazine hydrochloride and dextromethorphan hydrobromidePromethazine Dm · 1 product
- LactuloseKristalose, Lactulose Crystalline, Enulose · 1 product
- Valproic acid1 product
- AmantadineGocovri · 1 product
- NystatinNystop, Klayesta, Nyamyc · 1 product
- Megestrol acetate1 product
- Promethazine hydrochloridePhenergan, Promethegan · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| June 18, 2009 | ANDA077789 | Chlorhexidine gluconate CHLORHEXIDINE GLUCONATE | Pharmobedient |
| November 1, 2004 | ANDA076721 | Megestrol acetate MEGESTROL ACETATE | Pharmobedient |
| February 21, 2002 | ANDA075911 | Lactulose LACTULOSE | Pharmobedient |
| December 24, 1998 | ANDA075060 | Amantadine AMANTADINE HYDROCHLORIDE | Pharmobedient |
| July 1, 1986 | ANDA070868 | Valproic acid VALPROIC ACID | Pharmobedient Cnsltg |
| January 4, 1985 | ANDA088864 | Promethazine hydrochloride and dextromethorphan hydrobromide PROMETHAZINE W/ DEXTROMETHORPHAN | Pharmobedient |
| December 24, 1984 | NDA019125 | Chlorhexidine gluconate DYNA-HEX 4 | Xttrium |
| October 29, 1984 | ANDA062512 | Nystatin NYSTATIN | Pharmobedient |
| November 18, 1982 | ANDA087872 | Lidocaine LIDOCAINE HYDROCHLORIDE | Pharmobedient |
| November 18, 1982 | ANDA087881 | Lidocaine LIDOCAINE HYDROCHLORIDE | Pharmobedient |
| November 15, 1982 | ANDA087953 | Promethazine hydrochloride PROMETHAZINE PLAIN | Pharmobedient |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2017
-
June 1, 2017 · Class II · Terminated · D-0938-2017 · Chlorhexidine gluconate
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
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026