Elevated risk U.S. Food and Drug Administration

GUM Paroex Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups recall: Potential contamination with Burkholderia lata

Recall published 5+ years ago

Potential contamination with Burkholderia lata

GUM Paroex Prescription & OTC drugs — recalled prescription & otc drugsGUM Paroex Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)GUM Paroex Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Microbial contamination

This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

What the notice says: From information provided by the manufacturer, Sunstar Americas, Inc. , use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
December 31, 2020
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
GUM Paroex
Product type
Prescription & OTC drugs
Distribution
Nationwide
Reports of harm
To date, no adverse events have been reported to Precision Dose, Inc. related to this recall.

Products covered by this recall

Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups

What the company announced

Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level. Precision Dose, Inc. was notified by the manufacturer of the product, Sunstar Americas, Inc. , that this product may be contaminated with the bacteria Burkholderia lata .

From information provided by the manufacturer, Sunstar Americas, Inc. , use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such pneumonia and bacteremia. To date, no adverse events have been reported to Precision Dose, Inc. related to this recall.

The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis and the product impacted is:

Distributed in cases each containing 3 shrink-wrapped plastic trays each with 10 unit dose cups, 30-pack. NDC 68094-028-62

Distributed in cases each containing 10 shrink-wrapped plastic trays each with 10 unit dose cups, 100-pack. NDC 68094-028-61

Chlorhexidine Gluconate Oral Rinse was distributed nationwide in the USA to pharmaceutical wholesalers.

Precision Dose, Inc. is notifying its consignees directly and is arranging for return of all recalled product. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact Precision Dose, Inc. at 1 (800) 397-9228 (Monday-Friday, 8:00 AM to 4:30 PM Central Time) or by email to [email protected] . Consumers should contact their physician or healthcare provider if they have experienced problems that may be related to using this drug product.

Affected products and lot numbers follow below:

AFFECTED LOTS-Chlorhexidine Gluconate Oral Rinse USP, 0.12%

  • LOT NUMBER: 502037 · EXPIRATION DATE: 01/31/2021 · NDC NUMBER: 68094-028-61 68094-028-62
  • LOT NUMBER: 502040 · EXPIRATION DATE: 01/31/2021 · NDC NUMBER: 68094-028-61 68094-028-62
  • LOT NUMBER: 502043 · EXPIRATION DATE: 01/31/2021 · NDC NUMBER: 68094-028-61 68094-028-62
  • LOT NUMBER: 502494 · EXPIRATION DATE: 08/31/2021 · NDC NUMBER: 68094-028-61 68094-028-62
  • LOT NUMBER: 502757 · EXPIRATION DATE: 08/31/2021 · NDC NUMBER: 68094-028-61
  • LOT NUMBER: 502677 · EXPIRATION DATE: 09/30/2021 · NDC NUMBER: 68094-028-61
  • LOT NUMBER: 502693 · EXPIRATION DATE: 10/31/2021 · NDC NUMBER: 68094-028-61
  • LOT NUMBER: 502728 · EXPIRATION DATE: 10/31/2021 · NDC NUMBER: 68094-028-61
  • LOT NUMBER: 502759 · EXPIRATION DATE: 10/31/2021 · NDC NUMBER: 68094-028-62
  • LOT NUMBER: 502771 · EXPIRATION DATE: 11/30/2021 · NDC NUMBER: 68094-028-61 68094-028-62
  • LOT NUMBER: 502784 · EXPIRATION DATE: 11/30/2021 · NDC NUMBER: 68094-028-61
  • LOT NUMBER: 502824 · EXPIRATION DATE: 12/31/2021 · NDC NUMBER: 68094-028-61
  • LOT NUMBER: 502925 · EXPIRATION DATE: 02/28/2022 · NDC NUMBER: 68094-028-61

Patients should contact their physician or healthcare provider if they have additional questions or concerns. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Precision Dose, Inc.

Precision Dose, Inc. is an American company headquartered in the Midwest specializing in the commercial repackaging of unit dose products.

For more information:

Contact Us:

Phone: 1 (800) 397-9228

Email: [email protected]

Visit Us:

www.precisiondose.com

Company Contact:

Mark Franzen

1 (800) 397-9228 x226

[email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 27 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 0.12
  • 502037
  • 502040
  • 502043
  • 502494
  • 502757
  • 502677
  • 502693
  • 502728
  • 502759
  • 502771
  • 502784
  • 502824
  • 502925

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 1/31/2021
  • 01/31/2021
  • 08/31/2021
  • 09/30/2021
  • 10/31/2021
  • 11/30/2021
  • 12/31/2021
  • 02/28/2022

NDC number

On the carton and again on the bottle or blister label.

  • 68094-028-62
  • 68094-028-61

Package size

Match the net weight or the piece count on the front of the pack.

  • 15 mL
  • 30 pack
  • 100 pack

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

GUM Paroex — This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

  1. Stop eating it and keep it separate from other food.
  2. Clean and sanitise the fridge shelf, container or surface it was stored on.
  3. Read the official notice for the organism named — the advice for Listeria, Salmonella and hepatitis A is not the same.
  4. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Precision Dose Inc. — Consumers: Precision Dose, Inc., 1-800-397-9228, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was GUM Paroex prescription & otc drugs recalled?

Potential contamination with Burkholderia lata From information provided by the manufacturer, Sunstar Americas, Inc. , use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 0.12, 502037, 502040; best-by date 1/31/2021 or 01/31/2021. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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