FDA Advises Discontinued Use of PharmaTech Liquid Products Due to Contamination

In a recent advisory alert, the Food and Drug Administration warned medical professionals and pharmacies against the continued use of any liquid products manufactured by PharmaTech LLC out of Florida. This advisory is due to the discovery of Burkholderia cepacia (B. cepacia) which can cause potentially severe reactions and infections in people, especially those with poor health already.

Rugby Laboratories out of Michigan issues a voluntary recall after several complaints that the product might be linked to signs and symptoms, and in some cases, infection of B. cepacia. Some of the common signs and symptoms of the bacterial infection include wheezing, coughing, shortness of breath, fever, and congestion.

The infection can be fatal in some cases, particularly for people who have pre-existing immune conditions, those suffering from pneumonia or cystic fibrosis.

Stool softeners are used for patients who have undergone surgery, experienced a recent trauma such as a heart attack, and are given to women who have recently given birth. They work by increasing the amount of water that gets absorbed into the intestines, and the liquid makes it easier for people to have a bowel movement without pain or discomfort. The stool softeners made by PharmaTech come in liquid and pill form.

While all liquid products manufactured by PharmaTech have been pulled from hospital storerooms and pharmacies, there may be some people at home who have this product in their medicine cabinet. The most recent recall includes all lots that were produced by the manufacturing company. If you have taken this product and are experiencing side effects, contact the FDA through their website immediately to report the symptoms, and see your doctor as soon as possible.

Last year, Diocto stool softener was recalled because of the contamination of B. cepacia found on the liquid stool softener products produced by PharmaTech. Several incidents of infection were reported, but it has reached over 60 incidents in 8 states since. Patients who came down with infections experienced serious side effects and needed intensive medical care to treat the infection. Unfortunately, B. cepacia is an antibiotic-resistant form of infection, and it can be very difficult to treat the infection once it takes hold. Treatment attempts can be even more difficult for people with pre-existing conditions that impact the immune system.

The FDA has ordered the use of these products to stop immediately and encourages healthcare professionals to ensure they are using products not made by this manufacturer for the time being. B. cepacia is typically found in soil and water, and the initial infection has been traced to the contaminated water from PharmaTech LLC.

Products manufactured by PharmaTech have been distributed by several companies including Rugby Laboratories, as well as others including Major, Bayshore, Metron, Centurion, and Virtus.

While Dicto was back on the market within one month of last year’s recall, there is no timeline for the return of PharmaTech’s products to the market right now. Contamination is difficult to track, and much information will be needed to move forward. Updates will regularly be provided from the FDA as to the state of the recall and efforts moving forward.

Burkholderia Cepacia Infections are Serious and Can be Life Threatening

It’s unacceptable for a pharmaceutical company to have not one, but two recalls of their products due to contamination of a dangerous bacteria. The Hastings Law Firm is interviewing potential cases involving Diocto injuries across all 50 states. There are currently over 60 cases of infectious outbreaks linked to PharmaTech and Rugby brand products including Dicoto. If you or a loved one has contracted a B. Cepacia bacterial infection from exposure to tainted medicines contact our attorneys immediately.