{
  "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": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA040596"
        ],
        "brand_name": [
          "PROMETHAZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "PROMETHAZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-040",
          "68382-041",
          "68382-042"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PROMETHAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "992438",
          "992447",
          "992475"
        ],
        "spl_id": [
          "d461a206-0842-428f-ad9b-a4aac8193fe9"
        ],
        "spl_set_id": [
          "c0c0d4f0-8396-485b-a585-71df01491f6f"
        ],
        "package_ndc": [
          "68382-040-01",
          "68382-040-05",
          "68382-040-10",
          "68382-041-01",
          "68382-041-05",
          "68382-041-10",
          "68382-042-01",
          "68382-042-05",
          "68382-042-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R61ZEH7I1I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68285",
      "recalling_firm": "Zydus Pharmaceuticals USA Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1342-2014",
      "product_description": "PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only.  Manufactured by: Cadila Healthcared Ltd., India.  Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01",
      "product_quantity": "10,200 bottles",
      "reason_for_recall": "Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.",
      "recall_initiation_date": "20140508",
      "center_classification_date": "20140521",
      "termination_date": "20160226",
      "report_date": "20140528",
      "code_info": "Lot #: MN9081, Expiry: 09/2015"
    }
  ]
}