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August 15, 2016: FDA Provides Update On Burkholderia Cepacia Outbreak – Laxachem Organics Import Alert

Laxachem Organics Import Alert Announcement – The U.S. Food and Drug Administration (FDA) has placed Laxachem Organics Pvt. Ltd., Ahmednagar, Maharashtra, India, on import alert as of August 11, 2016, for refusing to allow FDA investigators to inspect the company’s facility. According to the announcement, the import alert stops all Laxachem pharmaceutical products from entering the United States legally.

Laxachem will remain on import alert until it has been fully inspected by FDA and found to meet U.S. standards.

Laxachem Organics Import Alert Information

The FDA stated that “Laxachem Organics manufactures active pharmaceutical ingredient (API) for repackagers, labelers, and wholesale drug distributors, some of which sell API to manufacturing facilities in the United States. According to Laxachem’s website, one of the drugs Laxachem manufactures is Docusate Sodium USP.”

The agency cautioned that “Companies that received API from Laxachem should not distribute the API or products containing the API to customers.”

Under the Federal Food, Drug and Cosmetic Act (FD&C Act), drugs, including APIs, made at a facility that denies, limits, or delays an FDA inspection are considered adulterated. Distribution of adulterated products is prohibited by the FD&C Act.

Multiple Products Including PharmaTech’s Docusate Have Been Recalled

Multiple products manufactured by PharmaTech and sold under the brand labels Rugby, Major, Bayshore, Centurion, Metron, and Vitrus have been recalled for potential Burkholderia cepacia contamination.

  • August 8, 2016: Manufacturer Pharmatech recalls multiple drug products, dietary supplements and vitamins sold under the Rugby, Major, Bayshore, Centurion, Metron, and Vitrus labels for potential Burkholderia cepacia contamination.
  • July 15, 2016: PharmaTech recalls Diotoc (docusate) Liquid, distributed by Rugby, due to product contamination. Following the receipt of two isolated complaints and learning that the FDA had received several adverse event reports of Burkholderia cepaica infections in patients, PharmaTech notified its distributors and customers of the Diocto Liquid Recall. Consumers, pharmacies, and healthcare facilities were advised to stop using and dispensing the recalled products immediately due to potential docusate Berkholderia cepacia contamination.

Burkholderia Cepacia Outbreak Update

On August 10, 2016, the U.S. Center for Disease Control and Prevention (CDC) announced that it had confirmed 60 outbreak cases from 8 states. The CDC is still investigating the matter and recommends that clinicians and patients not use any brand of liquid docusate sodium product as a stool softener or for any other medical purpose.

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.

Ducosate 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.

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