Glenmark Pharmaceuticals Inc., USA, has voluntarily recalled 6,528 bottles of its blood pressure medication in the United States. 

The recall is due to the detection of a low level of nitrosodimethylamine (NDMA), a potentially carcinogenic impurity, in the finished drug product. Nitrosamines, including NDMA, are classified as probable human carcinogens based on laboratory studies. The affected medication, which is used to treat hypertension, was distributed nationwide. Customers who have the recalled product are advised to contact their healthcare provider or pharmacist for further guidance.

Glenmark Pharmaceuticals, the US-based arm of the Mumbai-headquartered drug firm, is recalling 6,528 bottles of a medication used to treat high blood pressure in the American market. The recall is due to failed dissolution specifications, according to the US Food and Drug Administration (FDA). The affected lot of Diltiazem Hydrochloride extended-release capsules is being recalled, as reported in the FDA's latest Enforcement Report.

The affected lot, produced in India, is being recalled by New Jersey-based Glenmark Pharmaceuticals Inc due to "failed dissolution specifications," according to the USFDA. The FDA stated that an "Out of Specification (OOS)" result was reported in a dissolution test at the 12th month time point in a long-term stability study.

Glenmark initiated a Class II recall of the drug across the US on March 26 this year. According to the USFDA, a Class II recall is initiated when the 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.

India holds the position as the largest supplier of generic medicines, accounting for around 20 percent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories. Products manufactured in the country are shipped to over 200 countries worldwide, with Japan, Australia, Western Europe, and the US being the main destinations.

India boasts the highest number of companies compliant with the standards set by the US Food and Drug Administration (USFDA) among those with manufacturing plants located outside of the United States.

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Source: Business standard