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October 12, 2016: FDA Finds Outbreak Bacteria in PharmaTech Docusate

According to an October 12, 2016 FDA Update, the bacteria Burkholderia cepacia was found in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, Davie, Florida. This finding identified oral liquid docusate sodium manufactured by PharmaTech as the likely source of the recent multistate B. cepacia outbreak.

The B. cepacia bacteria was detected in the water system used to manufacture the liquid docusate sodium . These products were manufactured by PharmaTech and distributed and labeled by six firms: Rugby, Major, Bayshore, Metron, Centurion, and Virtus.
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PharmaTech Docusate Burkholderia Cepacia Outbreak Details

On August 10, 2016, the U.S. Center for Disease Control and Prevention (CDC) announced that it had confirmed 58 B. cepacia outbreak cases from 8 states.

PharmaTech Docusate Lawsuit Help

The Weinberg Law Firm is currently assisting those who have suffered Burkholderia cepacia infections linked to docusate liquid use. If you or a loved one has been injured by a contaminated docusate product and you would like information regarding a docusate lawsuit, please call The Weinberg Law Firm toll free at 1-877-934-6274. Our phones are answered 24/7.

About Burkholderia cepacia (B. cepacia)

Burkholderia cepacia (B. cepacia) is a type of bacterium that can be found in soil and water. B. cepacia bacteria are often resistant to common antibiotics, making infections difficult to treat.

According to CDC, “B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. B cepacia is a known cause of infections in hospitalized patients.”
B. cepacia can cause serious respiratory infections, especially in patients with cystic fibrosis.

PharmaTech Docusate (Diocto) Recall Information

PharmaTech released the following product description and product recall information for Diocto Liquid (docusate sodium solution):

“Diocto Liquid is used as a stool softener and is packaged in one pint (473 mL) bottles. All lots with NDC 0536-0590-85 are included in the recall. Diocto Liquid was distributed nationwide to wholesale and retail facilities including hospitals and pharmacies.”

The company further stated that “Use of docusate sodium liquid contaminated with B. cepacia may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.”

Consumers, pharmacies, and healthcare facilities that have product which is being recalled should stop using and dispensing them immediately.

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