Category Archives: Burkholderia

Research – Opportunistic Pathogens in Drinking Water Distribution Systems—A Review

MDPI

Abstract

In contrast to “frank” pathogens, like Salmonella entrocoliticaShigella dysenteriae, and Vibrio cholerae, that always have a probability of disease, “opportunistic” pathogens are organisms that cause an infectious disease in a host with a weakened immune system and rarely in a healthy host. Historically, drinking water treatment has focused on control of frank pathogens, particularly those from human or animal sources (like Giardia lambliaCryptosporidium parvum, or Hepatitis A virus), but in recent years outbreaks from drinking water have increasingly been due to opportunistic pathogens. Characteristics of opportunistic pathogens that make them problematic for water treatment include: (1) they are normally present in aquatic environments, (2) they grow in biofilms that protect the bacteria from disinfectants, and (3) under appropriate conditions in drinking water systems (e.g., warm water, stagnation, low disinfectant levels, etc.), these bacteria can amplify to levels that can pose a public health risk. The three most common opportunistic pathogens in drinking water systems are Legionella pneumophilaMycobacterium avium, and Pseudomonas aeruginosa. This report focuses on these organisms to provide information on their public health risk, occurrence in drinking water systems, susceptibility to various disinfectants, and other operational practices (like flushing and cleaning of pipes and storage tanks). In addition, information is provided on a group of nine other opportunistic pathogens that are less commonly found in drinking water systems, including Aeromonas hydrophilaKlebsiella pneumoniaeSerratia marcescensBurkholderia pseudomalleiAcinetobacter baumanniiStenotrophomonas maltophiliaArcobacter butzleri, and several free-living amoebae including Naegleria fowleri and species of Acanthamoeba. The public health risk for these microbes in drinking water is still unclear, but in most cases, efforts to manage Legionella, mycobacteria, and Pseudomonas risks will also be effective for these other opportunistic pathogens. The approach to managing opportunistic pathogens in drinking water supplies focuses on controlling the growth of these organisms. Many of these microbes are normal inhabitants in biofilms in water, so the attention is less on eliminating these organisms from entering the system and more on managing their occurrence and concentrations in the pipe network. With anticipated warming trends associated with climate change, the factors that drive the growth of opportunistic pathogens in drinking water systems will likely increase. It is important, therefore, to evaluate treatment barriers and management activities for control of opportunistic pathogen risks. Controls for primary treatment, particularly for turbidity management and disinfection, should be reviewed to ensure adequacy for opportunistic pathogen control. However, the major focus for the utility’s opportunistic pathogen risk reduction plan is the management of biological activity and biofilms in the distribution system. Factors that influence the growth of microbes (primarily in biofilms) in the distribution system include, temperature, disinfectant type and concentration, nutrient levels (measured as AOC or BDOC), stagnation, flushing of pipes and cleaning of storage tank sediments, and corrosion control. Pressure management and distribution system integrity are also important to the microbial quality of water but are related more to the intrusion of contaminants into the distribution system rather than directly related to microbial growth. Summarizing the identified risk from drinking water, the availability and quality of disinfection data for treatment, and guidelines or standards for control showed that adequate information is best available for management of L. pneumophila. For L. pneumophila, the risk for this organism has been clearly established from drinking water, cases have increased worldwide, and it is one of the most identified causes of drinking water outbreaks. Water management best practices (e.g., maintenance of a disinfectant residual throughout the distribution system, flushing and cleaning of sediments in pipelines and storage tanks, among others) have been shown to be effective for control of L. pneumophila in water supplies. In addition, there are well documented management guidelines available for the control of the organism in drinking water distribution systems. By comparison, management of risks for Mycobacteria from water are less clear than for L. pneumophila. Treatment of M. avium is difficult due to its resistance to disinfection, the tendency to form clumps, and attachment to surfaces in biofilms. Additionally, there are no guidelines for management of M. avium in drinking water, and one risk assessment study suggested a low risk of infection. The role of tap water in the transmission of the other opportunistic pathogens is less clear and, in many cases, actions to manage L. pneumophila (e.g., maintenance of a disinfectant residual, flushing, cleaning of storage tanks, etc.) will also be beneficial in helping to manage these organisms as well.

Taiwan – Bongkrekic acid found in restaurant hit by food poisoning outbreak (update)

Focus Taiwan

Taipei, April 2 (CNA) A toxin believed to be the key to a lethal food poisoning outbreak in a Taipei restaurant has been detected in one of the environmental samples taken from the restaurant’s kitchen, confirming the presence of Bongkrecik acid in the restaurant, according to officials and experts on Tuesday.

At a press conference on Tuesday morning, Taipei Mayor Chiang Wan-an (蔣萬安) said the toxin, Bongkrekic acid, was found on samples collected from a chopping board, two knives, and one of the chef’s hands in the Xinyi branch of Malaysian restaurant chain Polam Kopitiam on March 24.

Taiwan – Three staff members at food poisoning restaurant banned from leaving Taiwan

Focus Taiwan

The legal representative of Polam Kopitiam as well as a branch manager and a chef were banned from leaving the country by prosecutors Thursday for their “suspected involvement” in what is believed to be a food poisoning outbreak.

The case has left two dead and 17 seeking medical treatment as of Thursday, according to health authorities.

All of the people who fell sick dined at the restaurant’s branch in Xinyi District between March 19-23 and consumed dishes made of rice noodles.

Research – Microbial diversity and prediction function profiling of microbial communities in rose jam

Wiley Online

Abstract

The microbial diversity of rose jam was analyzed by high-throughput sequencing, along with functional prediction of the bacterial community. The results indicate that PseudomonasPantoea, and Burkholderia emerged were the top three dominant bacterial groups. Proteobacteria was particularly abundant in R4 (99.1%) and R6 (96.12%).

Abstract

The microbial diversity of rose jam was analyzed by high-throughput sequencing, along with functional prediction of the bacterial community. The results indicate that PseudomonasPantoea, and Burkholderia emerged were the top three dominant bacterial groups. Proteobacteria was particularly abundant in R4 (99.1%) and R6 (96.12%). Zygosaccharomyces, unclassified fungi, and Botrytis constituted the top three fungal groups. The presence of unclassified OTUs was observed in all samples, particularly in R6 (52.36%), R8 (45.28), and R9 samples (39.57%). Gene prediction using PICRUSt revealed the existence of multiple KEGG functional modules associated with human metabolism in each rose jam sample. The presence of a high abundance of functional genes indicated the microbial community’s diverse wide range of microgenetic resources that can be further explored for research purposes. The microbial community found in rose jam exhibits remarkable diversity and encompasses valuable functional information relevant to human health.

, unclassified fungi, and Botrytis constituted the top three fungal groups. The presence of unclassified OTUs was observed in all samples, particularly in R6 (52.36%), R8 (45.28), and R9 samples (39.57%). Gene prediction using PICRUSt revealed the existence of multiple KEGG functional modules associated with human metabolism in each rose jam sample. The presence of a high abundance of functional genes indicated the microbial community’s diverse wide range of microgenetic resources that can be further explored for research purposes. The microbial community found in rose jam exhibits remarkable diversity and encompasses valuable functional information relevant to human health.

USA – Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination – Burkholderia lata.

FDA

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

Visit Us:
www.precisiondose.comExternal Link Disclaimer

Company Contact:
Mark Franzen
1 (800) 397-9228 x226
mfranzen@precisiondose.com


Company Contact Information

Consumers:
Precision Dose, Inc.
 1-800-397-9228
 customercare@precisiondose.com

Product Photos

USA – Sunstar Americas Inc. Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

FDA

Schaumburg, Illinois, Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020.

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 as pneumonia and bacteremia.

To date, 29 adverse events have been reported to SAI related to this recall. Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.

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 is packaged as follows:

  • 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
  • 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified as shown in the images below

Paroex was distributed Nationwide to Dental offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies.

SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email us.pcr@us.sunstar.com on Monday-Friday from 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Affected products and lot numbers follow below:

Product name:Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Size/ Form:16 fl.oz. Amber Bottles

NDC #:052376-021-02

Product Code:1789P

Lots Recalled:ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

Product name:Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Size/ Form:4 fl.oz. Amber Bottles

NDC #:052376-021-04

Product Code:1788P

Lots Recalled:ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

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

Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

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

About Sunstar Americas Inc.

Sunstar Americas, Inc., a member of the Sunstar Group of companies, is a global organization headquartered in Switzerland that is a leader in the oral care industry and the manufacturer and distributor of the GUM and Butler Brands.

Original Press Release

Company Contact Information

Consumers:
Sunstar Americas
 1-800-528-8537
 us.pcr@us.sunstar.com
Media:
Greg Belair
 847-794-4241
 Greg.belair@us.sunstar.com

Product Photos

USA – Mavidon Issues Voluntary Worldwide Recall of LemonPrep® Tubes and Single Use Cups

FDA

LemonPrep tubes and cups

Company Announcement

Mavidon is voluntarily recalling 21 lots of LemonPrep® 4 ounce tubes and single use cups to user level. These products have been found to be contaminated with Burkholderia cepacia. The specific lots are listed below:

Product Product # Lot#
LemonPrep 4 oz Tubes MD0019-T 29824, 29901, 30006, 30145, 30236, 30352,
30675, 30729, 31138
LemonPrep Single Use Cups MD0019-SUP 29927, 30009, 30031, 30115, 30059, 30237,
30300, 30340, 30424, 30642, 30735, 31139

Burkholderia cepacia is a multi-drug resistant pathogenic microorganism. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threatening for patients with compromised immune systems, such as neonates, elderly, pregnant women, cancer patients, but also in previously healthy individuals. To date, Mavidon has received one report of adverse event in a neonate related to this product in recall. Additional testing is ongoing to determine if there are other affected lots.

USA – Multistate Outbreak of Burkholderia cepacia Complex Infections Associated with the Use of Medline Remedy Essentials No-Rinse Cleaning Foam

uuCDC 

 

Update May 21, 2018

CDC is collaborating with the Food and Drug Administration (FDA), state and local health departments, and healthcare facilities to investigate a recent outbreak of Burkholderia cepacia complex (Bcc) infections. As of May 21, 2018, CDC confirmed 15 cases of Bcc infections associated with use of Medline (Northfield, IL) Remedy Essentials No-Rinse Cleansing Foam. Seven infections were in patients in Pennsylvania, seven were in California, and one was in New Jersey. These patients were already hospitalized for acute conditions and acquired the infections while hospitalized.

As of May 8, 2018 FDA is advising health professionals and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing foam, manufactured by Shadow Holdings dba Bocchi Laboratories (Santa Clarita, CA), as these products might be contaminated with Bcc. Shadow Holdings dba Bocchi Laboratories has recalled certain lots of the product.

The FDA is investigating this matter further to determine whether any additional products or lots may present a risk to consumers.

B. cepacia complex bacteria are environmental pathogens. Infections can be transmitted through infection control lapses, including indirect contact via environmental surfaces. Person-to-person transmission is possible but less common. B. cepacia complex bacteria can grow in aqueous environments, can exhibit resistance to preservatives, and can cause contamination of liquid medications or other liquid products. These factors have led to previous healthcare-associated outbreaks of B. cepacia complex. For additional information on B. cepacia complex bacteria please visit: Burkholderia cepacia in Healthcare Settings(https://www.cdc.gov/hai/organisms/bcepacia.html).

Report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

The product recall notice and list of products can be found here: Medline Canada, Corp. recalls Remedy Essentials Foaming Cleanser

FDA Alert May 7, 2018 – Multistate Outbreak of Burkholderia cepacia Infections Associated with the Use of Medline Remedy Essentials No-Rinse Cleaning Foam  

Additional updates will be posted as they become available.

Hand Sanitiser Contaminated with Bacteria

Winipeg Free Press

TORONTO – A hand sanitizer meant to protect people from germs is being recalled because of bacterial contamination, Health Canada said Thursday.

Kimberly-Clark is recalling its Kleenex-brand Luxury Foam Hand Sanitiser after company testing detected bacteria that may pose serious health risks to people with weakened immune systems, especially those with the lung disorder cystic fibrosis.

The bacteria identified in the tested samples are from the Burkholderia cepacia group. These bacteria pose little risk to healthy people, but for those with immune systems weakened by other illnesses, the microbes can cause serious problems, including pneumonia and blood infection.