LANSOPRAZOLE Recall D-0738-2022
Description: Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.
LANSOPRAZOLE Recall D-0738-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0738-2022 |
| Event ID | 89871 |
| Brand | LANSOPRAZOLE |
| Generic Name | LANSOPRAZOLE |
| Manufacturer | LANSOPRAZOLE |
| Original Package? | 1 |
| Active Substance | LANSOPRAZOLE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 7,703 bottles |
| Recall Reason | Failed Dissolution Specifications; during long term stability testing. |
| Drug Classification | Class II |
| Drug Code Info | 20220406 |
| Product NDC | 55111-398 55111-399 |
| Product NUI | N0000175525 N0000000147 N0000009724 |
| Pharma Class (PE) | Inhibition Gastric Acid Secretion [PE] |
| Pharma Class (EPC) | Proton Pump Inhibitor [EPC] |
| Recall Initiation Date | 20220323 |
| Report Date | 20220406 |
| Classification Date | 20220331 |
| Address | 107 College Rd E Princeton, NJ 08540-6623 United States |
| Recalling Firm | Dr. Reddy's Laboratories, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 0K5C5T2QPG |
| Drug Application Number | ANDA091269 |
| Structured Product Labeling (SPL ID) | 8d7762a5-6f5f-c059-28f3-bc0fa509eaf4 |
| Structured Product Labeling (SPL Set ID) | 82174fcc-1b0f-2068-7fc4-db335b43b5e2 |
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