Drug major Cipla is recalling 4,800 bottles of Nevirapine extended release tablets used for the treatment of human immunodeficiency virus (HIV) from the American market, according to a report by the US health regulator.
As per the latest Enforcement Report by the United States Food and Drug Administration (USFDA), the reason for the recall of the bottles is 'failed dissolution specifications'.
Nevirapine extended release tablets, 400 mg in the 30-count bottle have been manufactured by Cipla at its Goa facility for Cipla USA Inc, it added.
The US health regulator has not yet classified the voluntary recall by the company, the report said.
Earlier, Cipla Ltd said "multiple headwinds" are likely to impact the company's performance in the second half.
Revenue growth during the July-September period decreased 1.71% to Rs 4,012 crore, while Ebitda (earnings before interest, taxes, depreciation and amortisation) fell 6.34% to Rs 753 crore over the same period last fiscal.
In a statement, Cipla managing director and global chief executive officer Umang Vohra said the company had a modest quarter but maintained a strong performance in private market segment across geographies, and its limited competition assets in the US are ramping up to drive quarter-on-quarter growth.
"As we enter the second half of this fiscal, multiple headwinds are likely to impact our reported performance. Having said that, we are focusing on positioning our businesses for long-term growth," he further said.