LANSOPRAZOLE Recall D-0853-2022
Description: 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.
LANSOPRAZOLE Recall D-0853-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0853-2022 |
| Event ID | 90021 |
| Brand | LANSOPRAZOLE |
| Generic Name | LANSOPRAZOLE |
| Manufacturer | LANSOPRAZOLE |
| Original Package? | 1 |
| Active Substance | LANSOPRAZOLE |
| Drug Route | ORAL |
| Distribution | OH |
| Quantity | 252 Blister Packs |
| Recall Reason | Failed Dissolution Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20220511 |
| Product NDC | 43598-560 43598-561 |
| Product NUI | N0000175525 N0000000147 N0000009724 |
| Pharma Class (PE) | Inhibition Gastric Acid Secretion [PE] |
| Pharma Class (EPC) | Proton Pump Inhibitor [EPC] |
| Recall Initiation Date | 20220415 |
| Report Date | 20220511 |
| Classification Date | 20220505 |
| 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 | ANDA210465 |
| Structured Product Labeling (SPL ID) | d07a82ca-89b1-abd0-efa4-5319fbe805c3 |
| Structured Product Labeling (SPL Set ID) | 656bc92a-1f95-047d-cd27-724073e63fe6 |
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