Top Indian drug makers issue several product recalls in U.S. market

India’s leading pharmaceutical firms, Dr. Reddy’s Laboratories, Jubilant Pharma, Sun Pharma (Sun Pharmaceutical Industries Ltd.), and Aurobindo Pharma have reportedly issued drug recalls in the United States, the world's largest market for pharmaceutical products, over a wide array of reasons.

According to the recent Enforcement Report from the USFDA (United States Food & Drug Administration), the Mumbai-based drug maker Sun Pharma has issued a recall for Cequa ophthalmic solution, which is primarily used for treating chronic dry eye disorder.

Sun Pharma’s U.S.-based subsidiary is recalling around 37,400 cartons (60 vials per carton) of ophthalmic solution owing to its ‘sub potent’ properties, said the U.S. health regulator.

Likewise, Dr. Reddy's Laboratories has recalled over 2,24,710 (500-count) and 10,440 (90-count) bottles of Atorvastatin Calcium tablets in the United States. The medication, which is used to avoid cardiovascular disease, is being recalled due to ‘failed impurities/degradation requirements,’ as claimed by the FDA.

Dr. Reddy’s U.S. unit issued a national recall in February 2021, which the USFDA classified as a Class III recall, meaning it was issued in a scenario in which an exposure to a violative product is unlikely to cause serious health consequences.

The Hyderabad-based drug-maker is also recalling 16,449 bottles of Progesterone Capsules (200 mg) in the U.S. market due to ‘failed dissolution requirements.’ For those unaware, Progesterone Capsules (200 mg) are used to cause menstrual cycles in women who have not yet reached menopause.

Meanwhile, Hyderabad’s Aurobindo Pharma is recalling 1,296 bottles of Famotidine tablets in the U.S. market due to the presence of foreign tablets, the FDA claims. Famotidine tablets are used to treat gastroesophageal reflux disease.

The USFDA noted that ibuprofen 400mg and famotidine 20mg tablets were found in famotidine 40mg. On January 20 this year, the company issued a national recall, which was treated as a Class II action by the USFDA.

Jubilant Cadista Pharmaceuticals is recalling 6,35,400 cartons of Methylprednisolone tablets, which are prescribed for immunosuppressive and anti-inflammatory effects, from the American market on the grounds of the illegible label.

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