{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA207306"
        ],
        "brand_name": [
          "ARFORMOTEROL TARTRATE"
        ],
        "generic_name": [
          "ARFORMOTEROL TARTRATE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-168"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "ARFORMOTEROL TARTRATE"
        ],
        "rxcui": [
          "668956"
        ],
        "spl_id": [
          "07b162cc-b71c-4750-a10b-2db80625012f"
        ],
        "spl_set_id": [
          "70071afd-5323-4019-aca5-5534278829dc"
        ],
        "package_ndc": [
          "69097-168-48",
          "69097-168-87",
          "69097-168-64",
          "69097-168-32",
          "69097-168-53"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "5P8VJ2I235"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90920",
      "recalling_firm": "CIPLA",
      "address_1": "10 Independence Blvd",
      "address_2": "N/A",
      "postal_code": "07059-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.",
      "recall_number": "D-1550-2022",
      "product_description": "Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ  07059.",
      "product_quantity": "9041 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility: environmental monitoring failure.",
      "recall_initiation_date": "20220929",
      "center_classification_date": "20220930",
      "termination_date": "20230725",
      "report_date": "20221012",
      "code_info": "Batch No: IA10082, IA10083, IA10084, IA10085, IA10086, exp. date 01/2023; IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130, exp. date 02/2023"
    }
  ]
}