UPDATED: FDA bans Indian API maker as it tracks source of Burkholderia cepacia outbreak

FDA sign

The FDA has banned all of the products made by an Indian drugmaker as it investigates an outbreak of dozens of hospital infections. 

In its most recent update on an outbreak of Burkholderia cepacia infections, the FDA said that in August, it placed Laxachem Organics on its import alert list after the Ahmednagar, Maharashtra- based company refused to allow FDA investigators to inspect its facility. It said that among the APIs the company is believed to make is docusate sodium.

It was drugs made from docusate sodium that the FDA in July found to be contaminated with Burkholderia cepacia and tied to an outbreak of infections. The outbreak was initially seen in some ventilated patients who were being treated in intensive care units but was later tied to other patients. At last count, the Centers for Disease Control said it had recorded 58 infections in 8 states.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

The contamination was confirmed in the docusate sodium constipation treatment, Diocto Liquid, manufactured by Davie, FL-based PharmaTech and distributed by a handful of companies. The CMO initially recalled only that product but then as a precaution expanded the recall to its 30 liquid products manufactured in the 9 months between Oct. 20, 2015, and July 15, 2016.

The FDA in its update on the outbreak said that Laxachem will remain on its import alert list until FDA investigators can confirm that its facility meets FDA standards. It said that companies that had bought APIs from Laxachem should not distribute the API or products containing the APIs to customers.

The report comes as the FDA continues to take action against Indian drugmakers that have not meet FDA standards. Last month, for example, it slapped Unimark Remedies with another warning letter in which it cited two of the Mumbai-based drugmaker’s plants for unsanitary conditions and poor record keeping.

- here’s the FDA update

Related Articles:
CMO expands drug recall over bacterial contamination concerns
CMO recalls constipation drug tied to bacterial infections reported in 5 states
FDA again slaps Indian API maker Unimark Remedies with warning letter over records, pests

Suggested Articles

Pfizer says two lots of migraine med Relpax failed to meet microbial standards and may be contaminated with genera pseudomonas and burkholderia.

Emcure has had its share of run-ins with the FDA in the past over the sterility of its plants. Now, it can notch one more black mark on its belt.

The FDA has slapped a warning letter on an Indian solvent recycler that may have contributed to the contamination of blood pressure meds.