Product Safety Recalls

Product Recall Tracker

LANSOPRAZOLE Recall D-1288-2022

Description: Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 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 4359856179, NDC 43598-561-78

LANSOPRAZOLE Recall D-1288-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1288-2022
Event ID90601
BrandLANSOPRAZOLE
Generic NameLANSOPRAZOLE
ManufacturerLANSOPRAZOLE
Original Package?1
Active SubstanceLANSOPRAZOLE
Drug RouteORAL
DistributionNationwide in the USA
Quantity2,639 cartons
Recall ReasonFAILED DISSOLUTION SPECIFICATIONS
Drug ClassificationClass II
Drug Code Info20220803
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 Date20220713
Report Date20220803
Classification Date20220722
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)dfac78f3-0f72-520c-52cb-d82d84c753be
Structured Product Labeling (SPL Set ID)656bc92a-1f95-047d-cd27-724073e63fe6
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