Health Risks and Impact on Patients
Glenmark Pharmaceuticals Inc., based in Mahwah, NJ, has announced a voluntary recall of 114 batches of its Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K.
The recall is prompted by failed dissolution tests, which can lead to dangerously high potassium levels, known as hyperkalemia.
This condition can cause irregular heartbeats, potentially leading to cardiac arrest. The risk is particularly high for patients with underlying health conditions such as hypertension, heart failure, or renal dysfunction, who require chronic use of these capsules.
While there have been no reported cases of hyperkalemia or other serious adverse events related to this recall, patients are advised to consult their healthcare providers.
Distribution and Identification of Affected Products
The recalled Potassium Chloride Extended-Release Capsules, used to treat hypokalemia, were distributed nationwide across wholesale, distributor, and retail outlets.
The affected products are packaged in bottles of 100-count (NDC 68462-357-01) and 500-count (NDC 68462-357-05) capsules. Glenmark is actively notifying its wholesale and distributor customers through written communication and coordinating the return of all recalled batches.
Retailers and distributors are instructed to halt the distribution of the affected lots immediately and follow the recall instructions provided by Glenmark.
Consumer Guidance and Reporting Adverse Reactions
Consumers in possession of the recalled capsules should seek advice from their physicians before discontinuing use.
Additionally, they should contact their healthcare providers if they have experienced any related health issues.
For return instructions and further information, consumers can reach Inmar Rx Solutions at 1-877-883-9273, Monday through Friday, from 9:00 am to 5:00 pm EST.
