Could cause temporary or reversible harm; serious harm is unlikely.
Failed Dissolution Specifications.
| Brand name | POTASSIUM CHLORIDE |
| Generic name | POTASSIUM CHLORIDE |
| Active ingredient(s) | POTASSIUM CHLORIDE |
| Distributed by / for | Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520 |
| NDC | 0904-7216-61 |
| Full product label | 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 |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories |
| Distribution | Nationwide in the USA |
| Quantity | 6997 cartons |
| Recall initiated | 2025-01-30 |
| Report date | 2025-02-12 |
| Recall completed | — |
| Recall number | D-0221-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | La Vergne TN United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗