new delhi nov 10 drug maker glenmark pharmaceuticals is recalling close to 217 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 companys usbased 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 companys 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 similarly the usbased arm of hyderabadbased aurobindo pharma is recalling one lot of ranitidine tablets 150mg at the retail level and 37 lots of ranitidine capsules 150mg ranitidine capsules 300mg and ranitidine syrup 15mgml at the consumer level due to detection of ndma nitrosodimethylamine impurity in the finished product usfda said ndma a substance that occurs naturally in certain foods drinking water air pollution and industrial processes has been classified as a probable human carcinogen as per the international agency for research on cancer iarc to date aurobindo pharma usa inc has not received any reports of adverse events related to this recall the us health regulator said ranitidine is used to decrease the amount of acid created by the stomach and relieves heartburn associated with acid indigestion and sore stomach the fda in a statement issued on september 13 had said it is working with international regulators and industry partners to determine the source of this impurity in ranitidine and examining levels of ndma in ranitidine and evaluating any possible risk to patients mss rvk