Glenmark recalls over 2 lakh cartons of product in US
Drug maker Glenmark Pharmaceuticals is recalling close to 2.17 lakh cartons of Estradiol Vaginal inserts in the US market due to faulty delivery system, as per a report by the American health regulator. The company's US-based arm is recalling the lots of the product used for providing relief from menopause symptom.
According to the latest Enforcement Report by the US Food and Drug Administration (USFDA), Glenmark Pharmaceuticals Inc USA is recalling the product in various strengths which was manufactured at company's Goa manufacturing facility.
The ongoing voluntary class II recall is on account of defective delivery system with "complaints for difficulty in pushing the plunger of the applicator", it added.
The recall is nationwide within the United States, the USFDA said.
As per USFDA, a class II recall is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".