Update: Ultrasound Gel Recalled for B. Cepacia Contamination
Eco-Med Pharmaceutical Inc. on August 4, 2021, issued a recall for ultrasound gels and lotions marketed by dozens of distributors under different names after the company received at least 66 reports of severe B. cepacia infections associated with the products.
"The use of affected ultrasound gels and lotions contaminated with Bcc may lead to serious infections, including bloodstream infections, which may result in sepsis or death," FDA said. "As of Aug. 31, 2021, there have been at least 66 infections, including 60 bloodstream infections associated with these affected products, per the Centers for Disease Control and Prevention (CDC)."
What is B. Cepacia?
Burkholderia cepacia is a type of antibiotic-resistant bacteria commonly found in the soil and water, according to the Centers for Disease Control and Prevention (CDC) . While the bacteria typically poses little threat to healthy adults, it can cause severe infections in people with weakened immune systems or chronic lung diseases like cystic fibrosis. The mortality rate associated with B. Cepacia infection is roughly 42%, according to the CDC.
B. Cepacia Outbreaks
Outbreaks of B. cepacia infection have been linked to the following products:
- Antiseptic wipes  - In August 2012, the Dukal Corporation announced a recall for selected lots of benzalkonium chloride swabs and antiseptic wipes over concerns about potential B. cepacia contamination.
- Baby wipes  - Nutek Disposables, Inc. issued a nationwide recall in October 2014 for baby wipes manufactured under the brand names Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain B. cepacia.
- Comfort Shield Barrier Cream Cloth - Recalled for potential B. cepacia contamination in August 2016. Affected products include Comfort Shield Barrier Cream Cloths, Incontinence Clean-Up Cloths, M-care Meatal Cleansing Cloths for the Foley Catheterized Patient, Comfort Bath Cleansing Washcloths, and 2% Chlorhexidine Gluconate Cloths.
- Body Milk  - 2008 study published in the Journal of Critical Care looked at 5 hospitalized patients who developed B. cepacia infections from unopened bottles of moisturizing body milk, “calling into question the use in critical care settings of cosmetic products that do not guarantee sterilization during the manufacturing process.”
- I.V. Flush Syringes - On October 5, 2016, Nurse Assist, Inc. recalled all unexpired lots of its I.V. flush syringes after reports of patients developing B. cepacia infections while receiving intravenous care using prepackaged saline flushes.
- Mouthwash  - Study published in the International Journal of Infectious Diseases (IJID) in December 2014 found contaminated alcohol-free mouthwash to be the source of B. cepacia colonization and infection in ICU patients undergoing mechanical ventilation.
- Stool softener  - In July 2016, the FDA and CDC announced they were investigating a multistate outbreak of B. cepacia linked to contaminated liquid docusate product that infected at least 60 people in 8 states.
Symptoms of B. Cepacia Infection
Signs and symptoms of B. cepacia infection include:
- Shortness of breath
Since B. cepacia is often resistant to common antibiotics, the infection is difficult to treat once its reached the lungs. However, some species may be successfully treated with a combination of antibiotics. Basic infection prevention and control practices can significantly reduce the risk of contracting or spreading B. cepacia.
Mavidon Issues Worldwide Recall for All Products Over B. Cepacia Contamination
Dec. 26, 2019 - Mavidon is recalling all its products -- Lemon Prep, Pedia Prep, Wave Prep, Cardio Prep Single use cups, Collodions, Collodion Remover, Medical Adhesive Remover, Acetone -- over potential contamination with B. cepacia, according to an FDA recall notice  issued Monday. The recall was issued out of an abundance of caution after a sample of Lemon Prep tested positive for the bacteria. Hospitals, distributors, and clinics that have any Mavidon products should immediately stop using the product and quarantine it, FDA said.
B. Cepacia Infections Linked to Medline Remedy Foaming Body Cleanser
May 9, 2018 - The U.S. Centers for Disease Control and Prevention (CDC) has received at least 10 reports of infection with B. cepacia bacteria associated with Remedy Essentials No-Rinse Cleansing Foam, according to an FDA Health Alert  issued Tuesday. The infections occurred in 3 states: Pennsylvania (7 cases), California (2 cases), and New Jersey (1 case). All patients were hospitalized with acute conditions at the time of diagnosis, FDA said.
PharmaTech Recalls ALL Liquid Meds for B. Cepacia Contamination
August 16, 2017 - For the 2nd time in 10 months, FDA is warning consumers to avoid liquid drugs manufactured by PharmaTech after discovering B. cepacia in the products. The sweeping recall action affects all-lots and expiration dates of 22 OTC liquid medications made by the company.
Liquid Stool Softeners Recalled for B. Cepacia Contamination
August 9, 2017 - Rugby Laboratories is recalling its Diocto liquid and Diocto syrup laxatives over potential contamination with B. cepacia, according to an FDA Recall Notice issued Tuesday. The agency notified Rugby of the problem after receiving several reports of infection in patients who had used the laxatives.
Get a Free B. Cepacia Lawsuit Case Evaluation With Our Lawyer
The Product Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in B. Cepacia infection lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Again, if you or a loved one was infected, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.