POTASSIUM CHLORIDE Recall D-0221-2025
Description: Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61
POTASSIUM CHLORIDE Recall D-0221-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0221-2025 |
| Event ID | 96201 |
| Brand | POTASSIUM CHLORIDE |
| Generic Name | POTASSIUM CHLORIDE |
| Manufacturer | POTASSIUM CHLORIDE |
| Active Substance | POTASSIUM CHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 6997 cartons |
| Recall Reason | Failed Dissolution Specifications. |
| Drug Classification | Class II |
| Drug Code Info | 20250212 |
| Product NDC | 0904-7216 |
| Recall Initiation Date | 20250130 |
| Report Date | 20250212 |
| Classification Date | 20250204 |
| Address | 341 Mason Rd La Vergne, TN 37086-3606 United States |
| Recalling Firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 660YQ98I10 |
| Drug Application Number | ANDA210921 |
| Structured Product Labeling (SPL ID) | cd2e424e-1609-444d-b515-986f430210ad |
| Structured Product Labeling (SPL Set ID) | a9d68a40-75e3-4c5c-b5d7-1d6160527fa7 |
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