D-0606-2024 Class II Ongoing
FDA drug recall D-0606-2024 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, 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 for Recall
CGMP Deviations
Distribution Pattern
Nationwide
Code Information
Lot #: 17230074, 17230221, Exp Dec-31-24; 17230468, 17230479, 17230553, 17230543, 17230561, Exp Jan-31-25; 17230619, 17230624, Exp Feb-28-25; 17230879, 17230890, 17230918, 17230984, 17230996, 17231002, 17231081, Exp Mar-31-25; 17231102, 17231135, 17231329, Exp Apr-30-25; 17231369, 17231513, Exp May-31-24; 17231516, 17231713, Exp Jun-30-25; 17231909, 17231903, Exp Jul-31-25; 17231943, Exp Aug-31-25; 17232166, 17232179, 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-0606-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026