Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due To Failed Dissolution
25 Jun 2024
MAHWAH, N.J. , June 25, 2024 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of
Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K
, to the consumer level.
The product is being recalled because of failed dissolution.
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Source: PRNewswire
Potassium Chloride Extended-Release Capsules USP
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Source: PRNewswire
Potassium Chloride Extended-Release Capsules USP
Risk Statement: 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. For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, 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. To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall.
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 Potassium Chloride Extended-Release Capsules being recalled were distributed nationwide to wholesale, distributor, and retail outlets.
The recall includes the lot numbers and expiration dates listed below:
Glenmark is notifying its wholesale and distributor customers by
written letters and is arranging for
return of all recalled batches. Wholesalers, distributors, and retailers that have the recalled products should discontinue distribution of the recalled product lots immediately and follow the instructions provided in the written recall letter. Wholesalers and distributors should conduct a sub-recall to retail or pharmacy customers.
Consumers that have Potassium Chloride Extended-Release Capsules subject to the recall should consult with their physician or health care provider before they
stop
using the product. 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.
Consumers should call Inmar Rx Solutions at 1-877-883-9273, Monday - Friday, 9:00 am – 5:00 pm EST for return instructions and for further information.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report
Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact: Glenmark Drug Safety
Phone Number: 1-888-721-7115
Photo 1 : https://mma.prnewswire.com/media/2447237/Glenmark_Product_Recall_1.jpg
Photo 2 : https://mma.prnewswire.com/media/2447238/Glenmark_Product_Recall_2.jpg
SOURCE Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
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