Class IOngoing

Potassium Chloride Extended-Release Capsules recall

FDA recall D-0604-2024 · initiated May 30, 2024

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

Failed Dissolution Specifications

Details

Product: Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-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 68462-357-01
Recalling company: Glenmark Pharms
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide
Initiated: May 30, 2024
FDA report date: Jul 24, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0604-2024 ↗

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