Cipla Limited, on Wednesday announced that it has received Establishment Inspection Report (EIR) from the US FDA for its Indore facility. Meanwhile, Sun Pharma has recalled 31,762 bottles of antidepressant drug in US, which were manufactured at its Halol plant.
Formal closure of US FDA inspection
According to a press statement Cipla Limited informed that the EIR indicates formal closure of the US FDA inspection conducted in July/August, 2015. Cipla's portfolio includes over 1000 products across wide range of therapeutic categories with one quality standard globally.
Sun pharma recalls antidepressant drug in US
Due to 'failed dissolution specifications, Sun Pharmaceutical Industries is recalling 31,762 bottles of bupropion hydrochloride extended- release tablets, which is used for treatment of major depressive disorder in the US . The recall is a class III recall. As per the USFDA, a class III recall is initiated in a situation "in which use of or exposure to a violative product is not likely to cause adverse health consequences."