FDA orders withdrawal of Wockhardt's insulin brand 'Wosulin'
25 November 2006
Mumbai: The Food and Drug Administration (FDA) in Maharashtra has expressed apprehensions about the quality of insulin manufactured by pharma major Wockhardt at its Aurangabad factory, and has asked the company to withdraw it from the market immediately. These insulin vials are branded as Wosulin.
FDA sources said that the administration is yet to do its own examination, but Wosulin branded insulin vials manufactured at Wockhardt''s Aurangabad facility have already been sent to the drug authorities in Andhra Pradesh, Tamil Nadu and Delhi. Samples of the drug have also been sent to the Central Research Institute in Kasauli, Himachal Pradesh for test and analysis.
Meanwhile, Wockhardt has started withdrawing the stocks from the market. The FDA order to withdraw all stocks of the Wosluin brand followed complaints received from consumers, reports said.
"We have received some reports about the quality of Wosulin vials and we are investigating the same. Prima facie it appears to be due to improper temperature during transit. Meanwhile, we are withdrawing the stocks as directed by the Maharashtra FDA," a spokesman for the company said.
Wockhardt had introduced the drug in 2003.