Voluntary Recall of Potassium Chloride Extended Release Capsules, USP due to Failed Dissolution

Port of Spain, July 04, 2024: The Ministry of Health (MoH), via its Chemistry, Food and Drugs Division advises of the voluntary recall of 114 batches of potassium chloride extended release capsules, USP (750mg) 10 mEq K. The recall was issued by Glenmark Pharmaceuticals Inc. due to failed dissolution.
Potassium Chloride Extended-Release Capsules are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68462-357-01) and 500-count (NDC 68462-357-05) capsules. 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 affected lot numbers with Expiration Dates and NDC number can be found on the Ministry’s website https://health.gov.tt/news-and-updates and is noted at the Appendix.

While the recalled products are not registered for use in Trinidad and Tobago, out of an abundance of caution, the Ministry advises persons who may be in possession of these recalled products to discontinue use immediately and to return the product to the place of purchase where possible.

Additional Information can be obtained by contacting the Office of the Director of the Chemistry, Food and Drugs Division via email at cfdd@health.gov.tt or phone at 217-4664 ext. 13101.

The Ministry of Health will continue to monitor the situation and advise the population as necessary.



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