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Glenmark medicines recall 20 generic medicines sold to patients in the US. This is because Indian factories and the Food and Drug Administration, which failed to comply with US manufacturing standards, determined that the broken drug could harm people.
In February, the FDA discovered cleaning and testing issues at a factory in Madhya Pradesh, India, which was subject to the Propopavica investigation last year. The current recalls mentioned in last week’s FDA enforcement report cover a variety of commonly prescribed medications, including those that treat epilepsy, diabetes, multiple sclerosis, heart disease and hypertension, among other illnesses. A complete list of recalled drugs is available here.
The agency determined that the drug could cause temporary or reversible harm, and that the possibility of a more serious problem is far from being possible. However, the FDA did not mention any symptoms that the defective drug could cause. Propublica asked the FDA and Glenmark for details, but neither responded.
Records show that Glenmark first warned wholesalers about the recall in a letter on March 13th. The letter suggests that Glenmark pulled the drug because of a potential cross-contamination. Thomas Callahan, executive director of Glenmark’s North American Regulations, writes that 148 batches of recalled drugs were made “in a shared facility” with two cholesterol-lowering drugs, Ezetimibe and its drug and simvastatin.
That’s a concern because the chemical structure of ezetimibe contains what is called beta-lactam rings. FDA safety experts pay attention to this as many beta-lactam drugs, especially penicillin, can cause life-threatening allergies and hypersensitivity reactions. It is the most commonly reported drug allergy in the United States due to its risk. The FDA requires manufacturers to take special precautions to prevent cross-contamination with drugs, including beta-lactam rings, even if they are not antibiotics.
Callahan wrote to a wholesaler in Glenmark, and the chemical structure of ezetimibe is not likely to cause such a hypersensitivity reaction. Nevertheless, Glenmark recalled the medicine “from a wealth of attention based on risk assessments,” writes Callahan. He added, “This recall is made with knowledge from the Food and Drug Administration.”
According to Callahan’s letter, the potential issues date back to the year. Executives wrote that Glenmark began shipping drugs on October 4, 2022.
In December, Propublica revealed that the Glenmark factory was in charge of recalling tablet recalls that could not melt properly and could harm people. At the time, the FDA had not tested plants before the Covid-19 pandemic, despite one of these recalls being linked to the death of a patient in the United States.
Approximately two months after the investigation was announced, FDA officials returned to the factory. This was the first agency inspection in five years. Inspectors discovered that Glenmark had not properly washed to prevent contamination of drugs containing other drug residues. Federal agents also said Glenmark routinely released several drugs to the US market using testing methods that were not properly verified, according to the testing report.
Furthermore, when drug problems are discovered in some Glenmark tests, the company sometimes declared that these results were invalid and “retested with a new sample to obtain a passing result,” the inspection report states. “The batch was eventually released to the US market.”
In a detailed report, inspectors listed drugs shipped to US customers affected by potential contamination and testing issues, but the FDA edits the page after the page and is unable to know which drugs are unsafe. An FDA lawyer said the information was withheld because it contained trade secrets or commercial information that was deemed privileged or confidential.
Propublica first asked Glenmark about the test on March 7 after obtaining the FDA report through the Freedom of Information Act. Glenmark warned the wholesaler about the recall less than a week later, but the company and the FDA did not tell Propublica.
Instead, a Glenmark spokesperson sent a statement that the company is “committed to working diligently with the FDA to ensure compliance with manufacturing operations and quality systems.” The FDA also said that potential compliance issues can only be discussed with the companies involved.
The FDA first publicly mentioned the recall in its April 8th execution report. This is like an electronic filing cabinet for recalls. Recalls will not appear on the FDA’s Recalls website, which compiles press releases written by pharmaceutical companies.
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Propublica asked the FDA and Glenmark why they didn’t reveal to the public that these drugs had been recalled, but neither of them responded.
Glenmark is caught up in a federal lawsuit claiming it recalls a chloride capsule made at the Madhya Pradesh factory that caused the death of a 91-year-old Maine woman in June. Last year, the FDA determined that Glenmark expanded release capsules, which have been recalled, could kill US patients because they could not dissolve correctly and lead to dangerous potassium spikes. In the court application, Glenmark denies liability for the woman’s death.
Since recalling that potassium chloride, Glenmark has been reported to federal regulators of eight deaths among those who took the recalled capsule, FDA records show. Companies must submit such reports so that agents can monitor drug safety. However, the FDA shared very little details, so Propublica was unable to independently verify what happened in each case. Generally, the FDA says that reports of these adverse events reflect the opinions of people who report harm and do not prove that the drug caused it.
