Check your medicine cabinet! 114 batches of Potassium Chloride capsules have been recalled by Glenmark Pharmaceuticals Inc. due to failed dissolution, which can cause high potassium levels (hyperkalemia), the FDA reported recently.
The recalled products includes 100-count (NDC 68462-357-01) and 500-count (NDC 68462-357-05) bottles of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, which were distributed nationwide. Find all of the details—including what to do if you have a bottle of the recalled medication—below.
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Potassium-Chloride Capsule Recall
This issue was recalled voluntarily by New Jersey-based company Glenmark Pharmaceuticals Inc., after it was discovered that the capsules, prescribed to patients with low potassium (hypokalemia), may result in failed dissolution.
"The failed dissolution of potassium chloride extended release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heart beat that can lead to cardiac arrest," The FDA reports, noting that patients requiring chronic use of potassium chloride extended-release oral capsules, "there is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life threatening adverse events of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death."
Wholesale and distributor customers nationwide, who have been notified by Glenmark via letters, are urged to discontinue distribution immediately.
The full list of lot numbers and expiration dates can be found here.
If you are in possession of one of the recalled bottles, the FDA notes that you should consult your physician or health care provider before discontinuing use. "Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product," the FDA writes.
For more information and return instructions, call Inmar Rx Solutions at 1-877-883-9273, Monday - Friday, 9:00 am – 5:00 pm EST.
To report adverse reactions, you can fill out a form online; www.fda.gov/MedWatch/getforms.htmdownload a form and send it via fax; or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Staying on top of recalls is crucial to ensure the health and safety of you and your family.
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Stay safe!
