{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bedminster",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA212506"
        ],
        "brand_name": [
          "DICLOFENAC SODIUM"
        ],
        "generic_name": [
          "DICLOFENAC SODIUM"
        ],
        "manufacturer_name": [
          "Alembic Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "62332-487"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DICLOFENAC SODIUM"
        ],
        "rxcui": [
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        ],
        "spl_id": [
          "9f0592a4-9652-4315-8f56-0774af4c5fb5"
        ],
        "spl_set_id": [
          "02e90e33-384f-4e29-b508-2503def22214"
        ],
        "package_ndc": [
          "62332-487-12"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0362332487127"
        ],
        "unii": [
          "QTG126297Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92581",
      "recalling_firm": "ALEMBIC PHARMACEUTICALS, INC.",
      "address_1": "550 Hills Dr Ste 104b",
      "address_2": "N/A",
      "postal_code": "07921-1537",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0941-2023",
      "product_description": "Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only,  Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12",
      "product_quantity": "2844 units",
      "reason_for_recall": "Defective Delivery System",
      "recall_initiation_date": "20230622",
      "center_classification_date": "20230724",
      "report_date": "20230802",
      "code_info": "Lot #: 220151, 220152, 220153, Exp. Date 11/2024"
    }
  ]
}