In August, the FDA referenced a Laxachem import alert on a page dedicated to the outbreak. The agency did not name Laxachem as the source of the bacterial contamination, but did identify the firm as a producer and exporter of docusate sodium, which is the ingredient (API) in the laxatives linked to the infections.
However, this week an FDA spokesman told us “FDA shared information as part of its ongoing investigation of the Burkholderia cepacia outbreak. Because we were unable to inspect Laxachem's facility, we could not rule out the active pharmaceutical ingredient (API) as a source of the outbreak.”
“Since we issued the import alert, laboratory evidence from FDA and CDC supports PharmaTech's water system as the source of this outbreak and does not indicate the API as a source.”
He added that: “Over the course of the outbreak, the FDA investigated all aspects of manufacturing associated with liquid docusate sodium, including the API suppliers. FDA will continue to monitor adverse event reports for B. cepacia related to oral liquid docusate sodium.”
No APIs to US
This fits with what Laxachem spokesman Divyesh Thakrar told us.
“We do not supply to anyone in the US nor were we planning to, so - under such circumstances - we did not expect any inspection from US FDA.”
Thakrar also said the address on the FDA import alert – Ahmednagar in Maharashtra – is incorrect. “Our plant is in Amravati and not in Ahmednagar” he told us adding that the Amravati facility “is the only manufacturing site we have. We will request FDA to correct this.”
Laxachem intends to request an inspection by the FDA to have the import alert removed. Thakrar said “now that we will need to clear the alert, we will approach the US FDA for inspection in a few months’ time.”
PharmaTech recalled a constipation medication - Diocto Liquid (NDC 0536-0590-85) – in July after it was linked to 46 cases of B. cepacia infection the US Centers for Disease Control and Prevention (CDC).
A month later PharmaTech recalled all liquid products made at its Davie, Florida manufacturing site since October last year citing a risk of contamination.
The products were made for Rugby Laboratories, Major Pharmaceuticals, Bayshore Pharmaceuticals, Centurion Labs and Vitrus Pharmaceuticals.