MUMBAI, April 15 India's Lupin Ltd is
recalling 9,210 bottles of infection-preventing drug Suprax
which failed a purity test in the United States, the U.S. Food
and Drug Administration said.
The Suprax recall is the second for India's fourth-largest
drugmaker by sales, after pulling nearly 65,000 bottles from the
U.S. in January last year because of discoloration.
Recalls are not uncommon among drugmakers. This year alone,
recalls have been conducted by all of Lupin's bigger local
rivals - Ranbaxy Laboratories Ltd, Sun Pharmaceutical
Industries Ltd and Dr. Reddy's Laboratories Ltd
The latest recalled bottles of Suprax, used to prevent or
treat bacteria-related infection, "did not meet specification in
total impurities", the FDA said on its website on Monday. (r.reuters.com/myk58v)
The FDA classified the incident as a Class III recall,
meaning use of or exposure to the drug is unlikely to cause any
adverse health consequences.
A Lupin spokesperson on Tuesday confirmed the recall, which
began in January, and said the company expects "no business
The recent recalls come amid increased FDA scrutiny of
medicines produced in India, which supplies about 40 percent of
generic and over-the-counter drugs sold in the U.S.
Indian drugmakers are heavily reliant on the U.S. where
Lupin, for instance, derives around 40 percent of sales.
In September, Lupin also recalled over 53,000 bottles of
hypertension drug quinapril from the U.S.
(Reporting by Zeba Siddiqui; Editing by Christopher Cushing)