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

FDA recall notice · announced July 12, 2017 · Xttrium Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Natiowide
Lot/code information: 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
Quantity: 36,720 16 oz. glass bottles
Status: Terminated
Products in this recall event:
- 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 (D-0938-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.