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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

Mandated?Voluntary: Firm initiated
Recall NumberD-0853-2022
Event ID90021
Original Package?1
Active SubstanceLANSOPRAZOLE
Drug RouteORAL
Quantity252 Blister Packs
Recall ReasonFailed Dissolution Specifications
Drug ClassificationClass II
Drug Code Info20220511
Product NDC43598-560 43598-561
Product NUIN0000175525 N0000000147 N0000009724
Pharma Class (PE)Inhibition Gastric Acid Secretion [PE]
Pharma Class (EPC)Proton Pump Inhibitor [EPC]
Recall Initiation Date20220415
Report Date20220511
Classification Date20220505
Address107 College Rd E
Princeton, NJ 08540-6623
United States
Recalling FirmDr. Reddy's Laboratories, Inc.
Initial Notification Letter
Unique Ingredient Identifier0K5C5T2QPG
Drug Application NumberANDA210465
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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