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Class II: temporary or reversible health riskTerminated

Xttrium Laboratories Chlorhexidine Gluconate 0 Recall

Chlorhexidine Gluconate 0

Xttrium Laboratories Inc · Chicago, IL

Risk level
Class II
Reported by FDA
Jul 12, 2017
Recall ID
D-0938-2017
Check your lot numberHow we source this data

Summary

Xttrium Laboratories recalled Chlorhexidine Gluconate 0 starting Jun 1, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0938-2017 on Jul 12, 2017. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Natiowide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0938-2017
Classification
Class II
Status
Terminated
Recall initiated
Jun 1, 2017
FDA report date
Jul 12, 2017
Quantity
36,720 16 oz. glass bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Xttrium Laboratories Inc

Original FDA data

Every field from FDA enforcement report D-0938-2017, exactly as published.

Show all FDA fields
City
Chicago
State
IL
Status
Terminated
Country
United States
Event ID
77443
Address
415 W Pershing Rd
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
Postal code
60609-2788
Report date
Jul 12, 2017
Product type
Drugs
Recall number
D-0938-2017
Classification
Class II
Recalling firm
Xttrium Laboratories Inc
Product quantity
36,720 16 oz. glass bottles
Termination date
Feb 19, 2018
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Natiowide
Recall initiation date
Jun 1, 2017
Initial firm notification
Telephone
Center classification date
Jul 2, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0938-2017, published Jul 12, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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