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

By Eric Palmer Sep 15, 2016 10:33am

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.

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

import alert Laxachem Organics Pharma