Glenmark Pharmaceuticals recalled two dozen common medicines sold by American patients because the Indian factory that made them not meet US production standards, and the nutrition management and medicines determined that faulty drugs could harm people, the federal records show.
In February, the FDA found problems with cleaning and testing at the Madhje Publishing Factory, India, which was the subject of the PROPBLICA investigation last year. Currently, the memory indicated in the FDA report last week covers a wide range of often prescribed drugs, including those who treat epilepsy, diabetes, sclerosis, heart disease and high blood pressure, among other ailments. A complete list Memories Medicines Available HERE.
The agency determined that drugs could cause temporary or reversible damage and that the chance of more serious problems was remote. However, the FDA did not say what symptoms may cause under -registered medicines. PROPUBLICA asked at the FDA and Glenmark for additional specifics but did not answer.
Records show that Glenmark first warned the wholesalers about the recall In a letter on March 13. This letter suggests that Glenmark pulled drugs due to potential cross-pollution. Thomas Kalagan, Executive Director for Regulation on North America Regulation, wrote that 148 parties withdrawn medicines were made “in a common object” with two drugs that reduce cholesterol, ezethimbe and a combination of this drug and symbol.
This causes care because the chemical structure of the Ezimiba contains what is known as a beta-lactic ring. FDA safety experts pay attention to this because many beta-lactamine, especially penicillin, can cause life-threatening allergies and hypersensitivity reactions. It Most often reported allergies for drugs In the US C -s this danger FDA requires to follow the manufacturers Special precautions to prevent cross -pollution With drugs that contain beta lact, even if they are not antibiotics.
The chemical structure of the Ezimib, Callagan wrote in the wholesalers Glenmark, shows that it is unlikely to cause such reactions of hypersensitivity. However, Glenmark was reminded of drugs, “based on risk assessment and with great caution,” Kallagan wrote. He added: “This memory is done with the knowledge of the Office of Nutrition and Medicines.”
According to a letter to Collage, the potential problem dates from years. The ruler wrote that Glenmark started sending drugs on October 4, 2022.
In December, Propublica showed that the Glenmark factory was responsible for the non -non -combined share of us that remembers pills that were not properly dissolved and could harm people. At the time, the FDA did not inspect the plant before the Covid-19 pandemic, though one of these appeals was related to the death of American patients.
Approximately two months after this investigation, FDA representatives returned to the factory – The first inspection of the agency for five years. Inspectors found that Glenmark did not properly clean the equipment to prevent contamination of medicines from other medicines. Federal investigators also noted that Glenmark regularly released some medicines to the American market using test methods that were not properly tested, the inspection said.
Moreover, when some Glenmark tests found drug problems, the company sometimes announced these results invalid and “repeated new samples to get the results,” the inspection said. “The parties were ultimately released on the American market.”
In Their detailed reportInspectors listed drugs sent to us by customers who have suffered from potential pollution and test problems, but the FDA censorship edited the page behind the page that it is impossible to find out which medicines may not be safe. The FDA prosecutor said the information was contained because it contained commercial secrets or commercial information that was considered privileged or confidential.
Propublica first asked Glenmark about this inspection on March 7 after receiving the FDA report through the Law on Freedom of Information. Glenmark warned wholesalers about the recall in less than a week, but the company and FDA did not report propublica.
Instead, the Glenmark press -secretary sent a statement saying that the company “sought to work conscientiously with the FDA to ensure production operations and quality systems.” And the FDA said he could discuss potential issues with the company’s participation.
FDA first mentioned the recall publicly on its April 8 Report on forced executionWhich is similar to the electronic submission of documents for recalls. Recalls do not appear on FDA resembles a web -sightCompile a press release written by pharmaceutical companies.
PROPUBLICA asked the FDA and Glenmark why they did not warn the public last month that this medicine was withdrawn, but none answered.
Glenmark is involved in a federal lawsuit, which claimed to resemble potassium chloride capsules made at his Madzha-Prades factory, caused the death of a 91-year-old Meng in June. Last year FDA determined that more than 50 million recalled the Glenmark capsules with a long release had the potential to kill US patients because they have not dissolved properly and can lead to a dangerous spike in potassium. Glenmark denied responsibility for the death of a woman in court statements.
From the fact that the recall of potassium chloride, Glenmark told the federal regulator that received reports of eight deaths in the United States people who took the withdrawn capsules, show FDA Records. Companies are obliged to submit such reports so that the agency can control drug security. However, the FDA shares several parts, so the propublica could not independently check what happened in each case. In general, the FDA states that these side -events reports reflect the opinions of people who reported harm and do not prove that the drug has caused it.
