{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020990"
        ],
        "brand_name": [
          "ZOLOFT"
        ],
        "generic_name": [
          "SERTRALINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "ROERIG"
        ],
        "product_ndc": [
          "0049-0050",
          "0049-4960",
          "0049-4900",
          "0049-4910"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SERTRALINE HYDROCHLORIDE"
        ],
        "rxcui": [
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          "208161",
          "212233",
          "312938",
          "312940",
          "312941",
          "861064",
          "861066"
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        "spl_id": [
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "0049-4960-30",
          "0049-4960-50",
          "0049-4900-30",
          "0049-4900-66",
          "0049-4900-73",
          "0049-4900-94",
          "0049-4900-41",
          "0049-4910-30",
          "0049-4910-66",
          "0049-4910-73",
          "0049-4910-94",
          "0049-4910-41",
          "0049-0050-01"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "UTI8907Y6X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "73913",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 E 42nd St",
      "address_2": "N/A",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0857-2016",
      "product_description": "Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.",
      "product_quantity": "68, 214 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.",
      "recall_initiation_date": "20160428",
      "center_classification_date": "20160520",
      "termination_date": "20170726",
      "report_date": "20160601",
      "code_info": "Lot #: M25569, Exp 08/18"
    }
  ]
}