Two Firms Recall Hypokalemia Medications

Potassium chloride products are being recalled by two firms, according to the October 20, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

Strides Pharma Inc is recalling 1813 bottles of potassium chloride extended-release tablets, 10 mEq (750 mg), 500-count bottles (NDC 64380-861-07), from lot 7240840A (Exp. 12/31/21). The tablets were manufactured by Strides Shasun Limited, Bengaluru, India, and distributed by Strides Pharma, East Brunswick, NJ, throughout the United States. The recall was initiated September 27, 2021, after samples failed to meet dissolution specifications. 

Additionally, SSM Health Care St Louis, doing business as SSM St. Clare Health Center, is recalling 385 bags of potassium chloride 40 mEq in 0.9% sodium chloride 270 mL NS, 250-mL bags (NDC 60652-6429-1), from lot 210806-015 (Exp. 11/4/21). The bags were distributed in Missouri. The recall was initiated September 22, 2021, due to sterility concerns.  

On October 8, 2021, the FDA designated both recalls Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists. 

Potassium chloride is available with a prescription to prevent or treat low levels of potassium in the blood and, when combined with sodium chloride, for intravenous replenishment of fluids and electrolytes.