A series of recalls from India-based company Glenmark Pharmaceuticals has raised concerns about the safety of drugs manufactured overseas and the FDA's role in ensuring public safety, ProPublica reported Dec. 12.
In May, Glenmark recalled nearly 47 million potassium chloride capsules due to a defect causing improper dissolution, which could lead to life-threatening spikes in potassium levels. Potassium chloride, used to treat low potassium levels, can be fatal at high doses.
Glenmark had previously issued six other recalls for similarly faulty medications produced at its factory in Madhya Pradesh, India. Despite repeated warnings regarding Glenmark's factories, the FDA has failed to act swiftly, raising concerns over the agency's oversight of foreign manufacturing plants, according to ProPublica.
The potassium chloride recall, considered one of the most serious by the FDA, was not widely publicized until nearly a month after Glenmark had notified distributors. In the wake of the recall, a federal lawsuit has been filed alleging the pills caused the death of a woman in Maine; a letter detailing the recall allegedly did not arrive until weeks after she died.
Patrick Stone, a former FDA inspector, told ProPublica the FDA "is always late to respond," pointing out that Glenmark's Madhya Pradesh factory had a history of issues. The FDA had not conducted an inspection of the factory since 2020 despite recurring concerns.