Mahwah, New Jersey-based Glenmark Pharmaceuticals Inc., USA, has recalled 114 batches of its Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, because of the product’s failure to dissolve, reports the FDA.
Initiated by Glenmark on June 24, 2024, the voluntary, consumer-level recall covers 100-count (NDC 68462-357-01) and 500-count bottles (NDC 68462-357-05) of Potassium Chloride Extended-Release Capsules, which are indicated for the treatment of patients suffering from hypokalemia, or low potassium. The products were distributed to wholesalers, distributors, and retail outlets across the U.S.
Officials say the product’s failure to dissolve may lead to high levels of potassium that can then cause an irregular heartbeat and possibly cardiac arrest. The issue poses the most risk to patients who rely on a chronic administration of potassium chloride extended-release oral capsules, and even more so in those with underlying co-morbidities, “or conditions that cause altered excretory mechanisms for potassium,” which include “hypertension, heart failure, or renal dysfunction.” This group has a higher likelihood of developing hyperkalemia that could advance into more severe adverse events, which may manifest as asymptomatic or as major, potentially life-threatening hyperkalemia events: cardiac arrythmias, serious weakness in muscles, and death.
While the company has not been alerted to any reports of hyperkalemia or other major adverse health outcomes related to the recall, anyone who may have affected capsule bottles is asked to consult with their healthcare provider about individual use of the product. Likewise, consumers should notify their physician in the event that they’ve experienced any health issues suspected to be connected to the drug product.
Since the FDA recall announcement, Glenmark has since notified its wholesale ad distributing partners about the issue via written communication, and a return program for all recalled batches has been established. Any wholesalers, distributors, or retailers who may be in possession of affected products are urged to discontinue all distribution. Partners should adhere to the instructions provided in the letter, and any retail or pharmacy customers who may have received a sub-distribution of affected products should be alerted of the recall immediately.
A complete list of all impacted lot numbers and expiration dates can be found in the FDA announcement.
For more recall information and return instructions, consumers should contact Inmar Rx Solutions at 1-877-883-9273. Calls are monitored Monday through Friday, from 9:00 a.m. to 5:00 p.m. Eastern Time.
As the FDA continues to oversee this recall, consumers are encouraged to report any adverse experiences or issues to the agency’s MedWatch Adverse Event Reporting program.
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