A trio of Indian drugmakers—Alembic Pharmaceuticals, Sun Pharmaceutical and Glenmark Pharmaceuticals—issued separate voluntary U.S. drug recalls in recent weeks due to either the presence of carcinogens or foreign matter in the products.
All of the recalls fall under the FDA’s Class II designation, which signifies that the products in question could cause temporary health issues and, in some rare cases, serious but not life-threatening problems.
Alembic recalled 9,492 bottles of the antidepressant doxepin hydrochloride in 10-mg capsules due to a deviation in its manufacturing process that resulted in a nitrosamine-related impurity above the level allowed by the U.S. drug agency. The FDA disclosed the recall in a routine enforcement update.
Nitrosomines are considered potential human carcinogens.
The meds, which were distributed nationwide, were manufactured in the company’s facility in Gujarat, India, for the company’s U.S. branch. The recall was issued by Alembic on July 25.
Meanwhile, Sun Pharma’s U.S. subsidiary based in Princeton, New Jersey, has issued a voluntary recall of 11,328 bottles of spironolactone in 25-mg tablets after it found the presence of aluminum in a finished product. Spironolactone is typically used to treat high blood pressure.
The lot under the recall was manufactured for Sun by Frontida BioPharm in Philadelphia and was distributed nationwide, according to the FDA update.
As for Glenmark, the company issued three separate recalls, with two of them covering more than 83,000 bottles of carvedilol tablets at various dosages. The drug is generally used to treat high blood pressure.
The pair of carvedilol recalls were initiated Aug. 6 and Aug. 7 due to the presence of a nitrosamine, according to FDA records. The drugs under recall were distributed across the U.S.
Two of the lots were manufactured in the company’s Madhya Pradesh facility in India, and three were produced at Glenmark’s Goa, India, plant.
Glenmark also issued a separate recall Aug. 8 for 22,656 bottles of theophylline extended-release tablets at the 400-mg dose. The drug is used to treat asthma and chronic obstructive pulmonary disease.
The recall was issued after a batch test failed to meet FDA dissolution and stability standards. The drugs were also produced by Glenmark in Goa and were distributed throughout the U.S.
Editor's note: This story was updated at 8:10 a.m. ET on Aug. 21 to correct the stated indication of spironolactone.