Recalls / Class II
Class IID-0938-2017
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
- Brand name
- Chlorhexidine Gluconate
- Generic name
- Chlorhexidine Gluconate
- Active ingredient
- Chlorhexidine Gluconate
- Route
- Oral
- NDC
- 0116-2001
- FDA application
- ANDA077789
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Xttrium Laboratories Inc
- Manufacturer
- Xttrium Laboratories, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 415 W Pershing Rd, N/A, Chicago, Illinois 60609-2788
Distribution
- Quantity
- 36,720 16 oz. glass bottles
- Distribution pattern
- Natiowide
Timeline
- Recall initiated
- 2017-06-01
- FDA classified
- 2017-07-02
- Posted by FDA
- 2017-07-12
- Terminated
- 2018-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0938-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.