FDA Recall D-0604-2024

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class I — life-threatening Ongoing 714 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: Lot#: 17221446, 17221445, Exp May-31-24; 17221393, 17221403, 17221405, 17221503, 17221508, Exp Jun-30-24; 17221567, 17221566, 17221719, 17221731, Exp Jul-31-24; 17221891, 17221892, 17221900, 17221992, 17222022, Exp Aug-31-24; 17222056, 17222043, 17222068, 17222079, 17222099, 17222103, 17222114, 17222119, 17222188, 17222199, 17222209, 17222200, Exp Sep-30-24; 17222265, 17222269, Exp Oct-31-24; 17222527, 17222530, 17222583, 17222586, 17230051, 17230075, 17230067, Exp Nov-30-24;

Quantity: 285,840 bottles

Reason for recall

Failed Dissolution Specifications

Recall record

Recall number: D-0604-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2024-05-30
Classified by FDA Center: 2024-07-17
FDA published: 2024-07-24
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): POTASSIUM CHLORIDE
Generic name(s): POTASSIUM CHLORIDE
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-357
Route(s): ORAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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