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The FDA first mentioned the recalls publicly in its April 8 enforcement report, which is like an electronic filing cabinet for recalls. The recalls do not appear on the FDA’s recalls website, which compiles press releases written by pharmaceutical companies. Trump’s DOJ Has Frozen Police Reform Work. Advocates Fear More Abuse in Departments Across the Country.
ProPublica asked the FDA and Glenmark why they didn’t alert the public last month that these medicines had been recalled, but neither responded.
Glenmark is embroiled in a federal lawsuit that alleges recalled potassium chloride capsules made at its Madhya Pradesh factory caused the death of a 91-year-old Maine woman in June. The FDA had determined last year that more than 50 million of those recalled Glenmark extended-release capsules had the potential to kill U.S. patients because they didn’t dissolve correctly and could lead to a perilous spike in potassium. In court filings, Glenmark has denied responsibility for the woman’s death.
Since that potassium chloride recall, Glenmark has told federal regulators it has received reports of eight deaths in the U.S. of people who took the recalled capsules, FDA records show. Companies are required to file such reports so the agency can monitor drug safety. The FDA shares few details, though, so ProPublica was unable to independently verify what happened in each case. In general, the FDA says these adverse event reports reflect the opinions of the people who reported the harm and don’t prove that the drug caused it.