The Block Firm’s investigation continues into Glenmark’s recall of tens of millions of potassium chloride extended-release capsules. Here is what we have learned so far and what The Block Firm is doing about it.
What is the Glenmark recall?
Glenmark Pharmaceuticals has recalled approximately 90 million capsules of potassium chloride extended-release due to a safety defect. Potassium chloride pills are required to release the active pharmaceutical ingredient, potassium chloride, slowly into the bloodstream. In technical terms, this is known as the dissolution time. Drugmakers are required to comply with the dissolution time specified by the U.S. Pharmacopoeia, a standard incorporated into federal and state law. If you’ve ever seen “USP” on your medicine bottle, that’s why. USP is an internationally recognized mark of drug quality. Drugs that do not comply with the USP standard are generally considered adulterated—illegal to sell and worthless. They also violate FDA’s Current Good Manufacturing Practices (CGMPs), minimum standards for safe drug-making.
Although Glenmark claimed that its potassium chloride complied with the USP standard and CGMPs, the massive recall proves that Glenmark’s representations were not true. Instead, Glenmark’s medicine was unsafe.
Why did Glenmark recall potassium chloride?
Glenmark recalled potassium chloride because of a safety defect which could cause the pills to dissolve too quickly, releasing the active ingredient at a harmful rate that can overwhelm the body and lead to cardiac and death. The defective capsules are considered adulterated. They are not safe or legal to sell and are worthless.
Is the recall serious?
Yes. According to the FDA, the Glenmark recall is a Class I recall, which means “there is a reasonable probability that the use of or exposure to” Glenmark’s potassium chloride capsules “will cause serious adverse health consequences or death.” Glenmark has since acknowledged that its defective drugs “may cause high potassium levels, also known as hyperkalemia, which can result in irregular heart beat that can lead to cardiac arrest.”
What are the side effects of Glenmark’s defective potassium chloride capsules?
Following the recall, Glenmark has admitted that the following side effects can occur as a result of the defect: cardiac arrythmias, cardiac arrest, severe muscle weakness, and death.
When did Glenmark recall potassium chloride extended-release capsules?
Glenmark first publicly acknowledged the defect on June 24, 2024, but according to FDA records, Glenmark knew about the problem before then. Unfortunately, it seems that Glenmark delayed notifying affected patients while they unknowingly took Glenmark’s defective pills, putting their health at serious risk.
What is Glenmark’s recall history?
According to our investigation, Glenmark has a history of serious safety violations. According to FDA records, the company has received multiple FDA Warning Letters, formal citations issued by the agency due to Glenmark’s “significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.” Among other deficiencies, Glenmark lacked appropriate policies and procedures, failed to investigate known quality problems, had inadequate laboratory controls, and failed to ensure that its drugs actually “have the identity, strength, quality, and purity” Glenmark represented. In addition, Glenmark has had to recall tens of millions of other drugs for serious safety and quality problems, including contamination with filth and carcinogens.
Should I consult my doctor?
If you’ve been affected by Glenmark’s recall, or if you think you might be experiencing side effects, you should consult your physician or the emergency department if you are experiencing a medical emergency. You should not change your medication without speaking to your personal health care professional first.
Is there a class action against Glenmark for the potassium chloride recall?
Yes. On August 30, 2024, The Block Firm filed a class action against Glenmark Pharmaceuticals Inc., USA, due to the potassium chloride recall. A class action is a special kind of lawsuit where the claims of millions of patients can be joined together in one case. The class action against Glenmark seeks to recover economic damages on behalf of Glenmark patients.
How can I learn more?
If you have been hurt by Glenmark’s recalled potassium chloride or would like to learn more about the class action and your legal rights, contact The Block Firm here.
