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
Reported: July 12, 2017 Initiated: June 1, 2017 #D-0938-2017
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
Details
- Recalling Firm
- Xttrium Laboratories Inc
- Units Affected
- 36,720 16 oz. glass bottles
- Distribution
- Natiowide
- Location
- Chicago, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Xttrium Laboratories Inc. Units affected: 36,720 16 oz. glass bottles.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 12, 2017. Severity: Moderate. Recall number: D-0938-2017.
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