Nationwide Potassium Chloride Capsule Recall
INVOLVES EXTENDED-RELEASE CAPSULES FROM GLENMARK PHARMACEUTICALS
Recalled Capsules In 114 Batches Were Distributed Nationwide
Glenmark Pharmaceuticals Inc. has announced a voluntary recall of 114 lots of potassium chloride extended-release capsules, USP (750 mg) 10 mEq K, due to dissolution failure.
The issue could potentially result in elevated potassium levels, known as hyperkalemia.
Hyperkalemia may cause irregular heartbeats and even cardiac arrest.
As of now, Glenmark has not received any reports of hyperkalemia or serious adverse events from independent sources associated with this recall.
The affected capsules, which came in bottles of 100-count (NDC 68462-357-01) and 500-count (NDC 68462-357-05), were distributed countrywide.
Glenmark Pharmaceuticals Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, India, founded in 1977.
potassium
mineral; electrolyte
assists in proper nerve function and muscles contraction
hyperkalemia
higher than normal potassium level in the blood
average or expected range: 3.6 to 5.2 millimoles per liter (mmol/L)
FDA Alert:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/glenmark-pharmaceuticals-inc-usa-issues-voluntary-nationwide-recall-potassium-chloride-extended