Recall: two drugs with prolonged release of potassium chloride

A total of 135 batches of potassium chloride capsules have been recalled because the extended release capsules might not release.

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Here’s what you need to know

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What’s been recalled?

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Glenmark Laboratories recalled 114 batches of 750 mg Potassium Chloride Extended-Release Capsules in bottles of 100 (NDC No. 68462-357-01) and 500 (NDC No. 68462-357-05) capsules. The batch numbers are in a PDF attached to the FDA recall notice posting.

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American Health Packaging on behalf of BluePoint Laboratories recalled 21 batches of the same capsules, also made by Glenmark and also in 100-count (NDC No. 68001-396-00) and 500-count (NDC No. 68001-396-03) packages. To see the batch numbers and expiration dates in the BluePoint recall, check the recall notice posting.

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Why has it been recalled?

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The capsules aren’t dissolving as they should, so they’re not working as they should. Potassium levels in users can get dangerously high, which is called hyperkalemia and “can result in irregular heart beat that can lead to cardiac arrest.”

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In people who need to use potassium chloride regularly to prevent high blood pressure, heart failure or kidney failure, hyperkalemia can lead to “more severe potential life threatening adverse events … such as cardiac arrhythmia, severe muscle weakness, and death.”

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What should you do now?

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Before you stop using the medications, talk to the prescribing medical professional about alternate treatments.

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If you have the capsules sold by Glenmark, call Inmar Rx Solutions at 877-883-9273, Monday through Friday from 9 a.m. to 5 p.m. Eastern time about returning the drugs.

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If you have the capsules sold by BluePoint, call Sedgwick at 855-695-8564, Monday through Friday from 8 a.m. to 5 p.m. Eastern time for return information.

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If you experience any medical problems from the capsules, talk to your medical professional. Then, notify the FDA MedWatch Adverse Event Reporting program, either online or by Fax. Forms are available online or by calling 800-332-1088.

This story was originally published June 29, 2024, 10:01 am.