Drug 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
D-0938-2017
Product summary
- Event
- Event 77443
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36,720 16 oz. glass bottles
- Official record key
drug-enforcement:D-0938-2017
Official wording
Reason: CGMP Deviations
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
Distribution pattern: Natiowide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations