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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