Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, ...
FDA Recall #D-0605-2024 — Class I — May 30, 2024
Product Description
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
Reason for Recall
Failed Dissolution Specifications
Recalling Firm
Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
36,630 bottles
Distribution
Nationwide
Code Information
Lot #: 17221197, 17221386, 17221385, Exp May-31-24; 17221489, 17221504, 17221530, Exp Jun-30-24; 17221561, 17221579, 17221568, 17221702, 17221704, Exp Jul-31-24; 17221898, 17221993, 17222029, Exp Aug-31-24; 17222300, 17222304, 17222278, 17222609, 17222395, Exp Oct-31-24; 17222589, 17222605, 17222613, Exp Nov-30-24;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated