Chlorhexidine Gluconate 0 — Class II drug recall D-0938-2017
Terminated recall by Xttrium Laboratories Inc, reported 2017-07-12. CGMP Deviations
| Recall number | D-0938-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xttrium Laboratories Inc, Chicago, IL, United States |
| Recall initiated | 2017-06-01 |
| Classified | 2017-07-02 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2018-02-19 |
| Quantity | 36,720 |
| Reason classes | cgmp |
| NDC | 00116-2001, 00116-2001-04, 00116-2001-05, 00116-2001-06, 00116-2001-07, 00116-2001-15, 00116-2001-16 |
| Lot numbers | 704-1999-201, 704-201, 705-1999-208, 705-208 |
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
Reason for recall
CGMP Deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0938-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.