Indian drugmaker Dr. Reddy's Laboratories has had its share of run-ins with the FDA over manufacturing problems at a suite of its facilities. Now, the company is pulling bottles of a generic heartburn med off shelves––for the second time in as many years––after failed quality testing.
Dr. Reddy's has voluntarily recalled 1,752 bottles of generic esomeprazole magnesium after tested lots showed discoloration and contained brown pellets, according to the FDA.
In late April, Dr. Reddy's launched the recall for 1,000-count bottles produced at its facility in Bachupally in Telangana, India. The drugmaker recalled 40,592 bottles of the same product produced at Bachupally back in February 2019, the FDA said. The Indian drugmaker's lasting problems with the generic heartburn med continue a series of run-ins with the FDA over the past few years. In February, Dr. Reddy’s reported (PDF) that issues outlined in an eight-observation Form 483 last August for its formulations facility in Duvvada, an area of Visakhapatnam in India, had been deemed "voluntary action initiated" by the agency.
That limited stamp of approval was a big step up for the drugmaker, which had at least a dozen Form 483s issued for its facilities since 2017, including one so far this year.
The Duvvada plant concerns followed a 2015 warning letter in which the FDA cited three of the company's Indian plants. Esomeprazole––sometimes marketed under the brand name Nexium––was one of a number of generic heartburn meds cleared by the FDA as safe after a global recall last year of generic and branded Zantac on carcinogen concerns.
In October, the FDA said preliminary tests of alternatives including Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) found no N-nitrosodimethylamine (NDMA), the suspected cancer-causing agent found in OTC ranitidine drugs including the popular Zantac.
Dr. Reddy's was one of a group of drugmakers to recall its in-house Zantac generics. The FDA later issued a global recall of all Zantac products after follow-up testing confirmed NDMA contamination.