FDA Alerts The Medical Community To Docusate Contamination And Docusate Recall
The Law Firm of Michael B. Serling is assisting a Michigan Client who has suffered a Burkholderia Cepacia Infection linked to Docusate liquid use.
In a company press release dated, July 15, 2016, PharmaTech LLC of Davie, FL, announced a recall for the company’s Docusate Sodium Solution due to the risk of B. Cepacia contamination. The product is distributed by Rugby Laboratories, Livonia, Michigan, under the brand name Diocto Liquid.
“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.”
On July 16, 2016, the FDA alerted healthcare professionals that PharmaTech is recalling all non-expired lots of Diocto Liquid, distributed by Rugby Laboratories. The FDA confirmed that the product has been contaminated with B. cepacia, a bacteria linked to an outbreak in five states.
The FDA and the U.S. Centers for Disease Control and Prevention (CDC) are working to identify other potentially contaminated docusate sodium liquid products. The FDA stated that it has received adverse event report of B. cepacia infections that identify liquid docusate products manufactured by companies other than Pharmatech.
The CDC reported outbreak update and recommendations on July 14, 2016. The CDC reported that 53 cases of B. cepacia infection across 5 states have been confirmed. The agency further stated “….both FDA and CDC continue to recommend that clinicians and patients not use any liquid docusate sodium product as a stool softener or for any other medical purpose.”
Consumers, pharmacies, and healthcare facilities that have product which is being recalled should stop using and dispensing them immediately.
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 Law Firm of Michael B. Serling at (248) 647-6966 or toll free at (800) 995-6991.