POTASSIUM CHLORIDE Recall D-0619-2024
Description: Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.
POTASSIUM CHLORIDE Recall D-0619-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0619-2024 |
| Event ID | 94946 |
| Brand | POTASSIUM CHLORIDE |
| Generic Name | POTASSIUM CHLORIDE |
| Manufacturer | POTASSIUM CHLORIDE |
| Original Package? | 1 |
| Active Substance | POTASSIUM CHLORIDE |
| Drug Route | ORAL |
| Distribution | US Nationwide. |
| Quantity | 61,231 bottles |
| Recall Reason | Failed Dissolution Specifications |
| Drug Classification | Class I |
| Drug Code Info | 20240807 |
| Product NDC | 68001-396 |
| Recall Initiation Date | 20240625 |
| Report Date | 20240807 |
| Classification Date | 20240728 |
| Address | 2550 John Glenn Ave Ste AN/A Columbus, OH 43217-1188 United States |
| Recalling Firm | Amerisource Health Services LLC |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | 660YQ98I10 |
| Drug Application Number | ANDA202868 |
| Structured Product Labeling (SPL ID) | 431ff2ef-567c-4b60-af43-f4da61febaad |
| Structured Product Labeling (SPL Set ID) | 431ff2ef-567c-4b60-af43-f4da61febaad |
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