cGMPs / Over-the-Counter

Sun Pharma recalls over 17.5K bottles of nasal spray in U.S.

Feb 23, 2018

Sun Pharmaceutical Industries, the U.S. arm of India’s Sun Pharma, is recalling over 17.5 thousand bottles of antihistamine nasal solution from the American market.

Per the FDA enforcement report for week of February 21, 2017 Sun is voluntarily recalling 17,554 bottles of Azelastine HCl Nasal Solution. The solution was manufactured at Sun's Halol facility, a key plant for the drugmaker. According to news reports, the U.S. FDA will soon begin a critical re-inspection  of the Halol manufacturing facility, after several reports of GMP issues. The Halol site, when fully operational, contributes as much as 15 percent of Sun Pharma's U.S. revenues.

The recent recall, a class III recall (not likely to cause adverse health consequences), is due to failure in meeting the relative standard deviation in a particular test during the 6-month long term stability test station.