Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0738-2022
Event ID89871
BrandLANSOPRAZOLE
Generic NameLANSOPRAZOLE
ManufacturerLANSOPRAZOLE
Original Package?1
Active SubstanceLANSOPRAZOLE
Drug RouteORAL
DistributionNationwide in the USA
Quantity7,703 bottles
Recall ReasonFailed Dissolution Specifications; during long term stability testing.
Drug ClassificationClass II
Drug Code Info20220406
Product NDC55111-398 55111-399
Product NUIN0000175525 N0000000147 N0000009724
Pharma Class (PE)Inhibition Gastric Acid Secretion [PE]
Pharma Class (EPC)Proton Pump Inhibitor [EPC]
Recall Initiation Date20220323
Report Date20220406
Classification Date20220331
Address107 College Rd E
Princeton, NJ 08540-6623
United States
Recalling FirmDr. Reddy's Laboratories, Inc.
Initial Notification Letter
Unique Ingredient Identifier0K5C5T2QPG
Drug Application NumberANDA091269
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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