LANSOPRAZOLE Recall D-1287-2022
Description: Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78
LANSOPRAZOLE Recall D-1287-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1287-2022 |
Event ID | 90601 |
Brand | LANSOPRAZOLE |
Generic Name | LANSOPRAZOLE |
Manufacturer | LANSOPRAZOLE |
Original Package? | 1 |
Active Substance | LANSOPRAZOLE |
Drug Route | ORAL |
Distribution | Nationwide in the USA |
Quantity | 2,892 cartons |
Recall Reason | FAILED DISSOLUTION SPECIFICATIONS |
Drug Classification | Class II |
Drug Code Info | 20220803 |
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 | 20220713 |
Report Date | 20220803 |
Classification Date | 20220722 |
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) | dfac78f3-0f72-520c-52cb-d82d84c753be |
Structured Product Labeling (SPL Set ID) | 656bc92a-1f95-047d-cd27-724073e63fe6 |
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