{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Aurangabad",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208706"
        ],
        "brand_name": [
          "DULOXETINE"
        ],
        "generic_name": [
          "DULOXETINE"
        ],
        "manufacturer_name": [
          "Ajanta Pharma USA Inc."
        ],
        "product_ndc": [
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          "27241-098",
          "27241-164",
          "27241-099"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DULOXETINE HYDROCHLORIDE"
        ],
        "rxcui": [
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          "596930",
          "596934",
          "616402"
        ],
        "spl_id": [
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        "spl_set_id": [
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        ],
        "package_ndc": [
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          "27241-097-10",
          "27241-097-90",
          "27241-097-05",
          "27241-098-03",
          "27241-098-09",
          "27241-098-10",
          "27241-164-30",
          "27241-099-03",
          "27241-099-90",
          "27241-099-40"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0327241164309",
          "0327241099038",
          "0327241097065",
          "0327241098031"
        ],
        "unii": [
          "9044SC542W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98785",
      "recalling_firm": "Ajanta Pharma Ltd.",
      "address_1": "B-4/5/6 MIDC Industrial Area",
      "address_2": "Paithan",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within U.S",
      "recall_number": "D-0515-2026",
      "product_description": "Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03",
      "product_quantity": "77,376 packs.",
      "reason_for_recall": "CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.",
      "recall_initiation_date": "20260429",
      "center_classification_date": "20260504",
      "report_date": "20260513",
      "code_info": "Lot#: PA07434, Exp. May 2026.",
      "more_code_info": ""
    }
  ]
}