{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-03-18", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Mahwah", "state": "NJ", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Drugs", "event_id": "84516", "recalling_firm": "Glenmark Pharmaceuticals Inc., USA", "address_1": "750 Corporate Dr", "address_2": "N/A", "postal_code": "07430-2009", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Press Release", "distribution_pattern": "Natiowide", "recall_number": "D-0644-2020", "product_description": "Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05", "product_quantity": "1,712,632 bottles", "reason_for_recall": "CGMP Deviations: Presence of NDMA impurity detected in product.", "recall_initiation_date": "20191217", "center_classification_date": "20200105", "report_date": "20200115", "code_info": "7701034A 7701057A 7701058A 7701059A 7701060A 7701061A 7701071A 7701072A 7701073A 7701074A 7701105A 7701106A 7701107A 7701108A 7701109A 7701113A 7701114A 7701115A 7701116A 7701121A 7701122A 7701123A 7701124A 7701125A 7701126A 7701151A 7701152A 7701165A 7701154A 7701155A 7701163A 7701176A 7701190A 7701221A 7701222A 7701223A 7701224A 7701225A 7701235A 7701253A 7701254A 7701255A 7701256A 7701257A 7701258A 7701259A 7701266A 7701267A 7701268A 7701273A 7701275A 7701276A 7701277A 7701294A 7701295A 7701296A 7701297A 7701300A 7701301A 7701302A 7701303A 7701304A 7701306A 7701307A 7701308A 7701309A 7701310A 7701311A 7701312A 7701313A 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