June 2017 FDA Recall Chlorhexidine Gluconate by Xttrium Laboratories Inc
D-0938-2017 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Xttrium Laboratories Inc on June 1, 2017 for the product Chlorhexidine Gluconate. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Natiowide and the recall is currently terminated.
Recall Number: D-0938-2017
CGMP Deviations
06-01-2017
07-12-2017
36,720 16 oz. glass bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Xttrium Laboratories Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Natiowide
02-19-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# 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
