On June 24, 2024, the FDA published a recall of certain batches of Glenmark Pharmaceuticals’ Potassium Chloride Extended Release Capsules because they failed to meet the required dissolution specifications. According to the FDA, due to this defect, the “capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heart beat that can lead to cardiac arrest” and other “adverse events . . . such as cardiac arrythmias, severe muscle weakness, and death.”
Because the FDA has determined that “there is a reasonable probability that the use of or exposure to” these defective capsules “will cause serious adverse health consequences or death,” the FDA has designated the recall Class I—the most serious kind. This Class I recall involves over 300,000 bottles or 46 million capsules. The FDA has since issued a Class II recall of many additional lots for failing to meet FDA-required Current Good Manufacturing Practices. These safety failures by Glenmark are part of a recent pattern of illegal drug-making practices, which has led to multiple Warning Letters (see here and here) from the FDA.
If you take Potassium Chloride Extended-Release Capsules from Glenmark, you may have legal claims against the company. The Block Firm is investigating a potential class action against Glenmark, which is an important tool for maintaining the integrity of the U.S. drug supply system. However, please do not stop taking your medication without consulting with your physician, who will be able to guide you about the risks and benefits of your specific medication regimen.
If you are interested in learning more, please contact the experienced class action attorneys at The Block Firm
