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Manufacturer Recall of Potassium Chloride Extended-Release Capsules

Recently, Glenmark Pharmaceuticals recalled 114 batches of 750 mg. potassium chloride extended-release capsules USP 10 mEq because of dissolution failure. The failed dissolution of these capsules can result in high potassium levels, a condition called hyperkalemia. This can lead to a patient’s cardiac arrest. Normal potassium levels are essential to your body; potassium assists with the functioning of kidneys, heart, muscles, nerves, and cells. If you were harmed by any of the recalled potassium chloride extended release capsules, consult the seasoned Chicago-based dangerous drug attorneys of Moll Law Group about your legal options.

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As a patient, you may need to take potassium chloride extended release capsules orally, especially if you have an underlying medical condition that changes how potassium is excreted. Such underlying conditions include heart failure, renal dysfunction or hypertension. Each of these  make it reasonably probable that you would develop hyperkalemia and cause severe adverse events. While it’s possible you might be asymptomatic, there is a chance you would suffer serious muscle weakness, cardiac arrhythmia, or even death.

The recalled capsules had been distributed around the country to wholesalers, distributors, and retail stores in 100-count and 500-count bottles. The manufacturer hasn’t yet gotten reports of hyperkalemia, or a serious adverse event related to the capsules. are packaged in 100-count (NDC 68462-357-01) and 500-count (NDC 68462-357-05) bottles.

Patients have been asked to talk to their doctor before stopping use of the capsules. They are also asked to consult their doctor if they’ve suffered any trouble that they think is related to taking or using the product. Meanwhile those selling and distributing the recalled capsules are expected to discontinue distribution of the product lots immediately and follow the instructions in the written recall letter that they’ve been sent. Doctors and other health care providers have been asked to report any adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

When a patient is injured by a dangerous drug, he or she may file a product liability lawsuit to recover compensation. A drug can be defective in terms of its manufacturing, marketing, or design (formulation). Generally, manufacturing defects are problems with how the drug was made; they are typically limited to one or a couple of lots of the medicine. Design defects are flaws that exist in every product; in this case, it seems likely that the capsules have flaws in how they’re designed. Marketing defects often involve failure to warn or errors and insufficient information in the product packaging and materials. Depending on the jurisdiction of a product liability lawsuit, our attorneys may be able to establish a drug manufacturer’s liability under theories of negligence, strict liability, breach of warranty, breach of contract, or statutory or regulatory violations.

In some cases, it may also be appropriate to bring a medical malpractice lawsuit against doctor who prescribes medication that has already been recalled. This lawsuit will likely rest on theories of negligence.

If you were injured by your use of potassium chloride extended release capsules, call the seasoned Chicago-based dangerous drugs lawyers of Moll Law Group for a consultation. We represent plaintiffs injured by dangerous drugs around the country. Please complete our online form or call us at 312.462.1700.