D-0938-2017 Class II Terminated

Recalled by Xttrium Laboratories Inc — Chicago, IL

Recall Details

Product Type
Drugs
Report Date
July 12, 2017
Initiation Date
June 1, 2017
Termination Date
February 19, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36,720 16 oz. glass bottles

Product Description

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

Distribution Pattern

Natiowide

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