While the USFDA inspection rumors kept the Sun Pharma stock under pressure, the negative news regarding the drug recall has added to the pressure for the company.
As per the enforcement report for the week of February 21, 2017 of the US FDA, Sun Pharma has recalled over 17,554 bottles of Azelastine HCl Nasal spray from US. The USFDA website has indicated that Sun Pharmaceuticals is recalling Azelastine HCl Nasal Solution, 0.1 percent (30 mL Bottle) due to failure in meeting the relative standard deviation in a particular test during the 6-month long term stability test station. This is a class III recall (products unlikely to cause any adverse health reaction, but violate FDA labeling laws), which is minor in nature as per the regulator’s classification.
The USFDA website further states that the drug was manufactured by Sun Pharmaceutical at Halol, which if believed as per the media reports, is undergoing the regulatory inspection. The Halol facility is its most important plant for the company, and the company's future growth, to a great extent, is dependent upon the clearance of this plant.
The company, on November 24, 2017 had voluntarily recalled two lots of diabetes drug Riomet (Metformin Hydrochloride Oral Solution) due to microbial contamination. This was a class II recall, meaning products might cause a temporary health problem or pose only a slight threat of a serious nature. ¬ - IIFL