D-0607-2024 Class II Ongoing
FDA drug recall D-0607-2024 was initiated by Glenmark Pharmaceuticals Inc., USA on May 30, 2024 and is designated Class II. Reason for recall: CGMP Deviations The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 24, 2024
- Initiation Date
- May 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
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
CGMP Deviations
Distribution Pattern
Nationwide
Code Information
Lot #: 17230186, 17230192, 17230213, 17230278, 17230399, Exp Dec-31-24; 17230406, 17230412, 17230427, 17230444, 17230453, 17230495, Exp Jan-31-25; 17230574, 17230585, 17230608, 17230629, Exp Feb-28-25; 17230883, 17230921, Exp Mar-31-25; 17231087, 17231339, Exp Apr-30-25; 17231360, Exp May-31-25; 17231711, 17231745, Exp Jun-30-25; 17231819, 17231820, 17231936, 17231957, Exp Jul-31-25; 17231998, 17232012, Aug-31-25; 17232110, Exp Sep-30-25; 17232114, Exp Aug-31-25; 17232119, 17232343, Exp Sep-30-25.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0607-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026