FDA Drug recall D-0604-2024
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals…
- FDA Drug
- Class I
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class I recall of Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals… by Glenmark Pharmaceuticals Usa, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0604-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-05-30 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 68462-357-90 |
|---|---|
| ndc | 68462-357-01 |
| ndc | 68462-357-05 |
| code_info | Lot#: 17221446, 17221445, Exp May-31-24; 17221393, 17221403, 17221405, 17221503, 17221508, Exp Jun-30-24; 17221567, 17…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; |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0604-2024%22
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