Could cause temporary or reversible harm; serious harm is unlikely.
Failed Dissolution Specifications
| Brand name | LANSOPRAZOLE |
| Generic name | LANSOPRAZOLE |
| Active ingredient(s) | LANSOPRAZOLE |
| Distributed by / for | Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540 |
| NDC | 43598-561-78 |
| Full product label | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78. |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Distribution | OH |
| Quantity | 252 Blister Packs |
| Recall initiated | 2022-04-15 |
| Report date | 2022-05-11 |
| Recall completed | 2023-11-07 |
| Recall number | D-0853-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗