{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208961"
        ],
        "brand_name": [
          "CLOMIPRAMINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CLOMIPRAMINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Northstar Rx LLC."
        ],
        "product_ndc": [
          "16714-849",
          "16714-850",
          "16714-851"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CLOMIPRAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "857297",
          "857301",
          "857305"
        ],
        "spl_id": [
          "57601a94-de02-4050-bbcf-fd7e6ac25825"
        ],
        "spl_set_id": [
          "b1809cb2-c6a8-451a-b692-506456c4efc3"
        ],
        "package_ndc": [
          "16714-849-02",
          "16714-849-01",
          "16714-849-03",
          "16714-850-01",
          "16714-850-03",
          "16714-850-02",
          "16714-851-01",
          "16714-851-03",
          "16714-851-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "2LXW0L6GWJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97856",
      "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": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0153-2026",
      "product_description": "clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India",
      "product_quantity": "N/A",
      "reason_for_recall": "cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.",
      "recall_initiation_date": "20251022",
      "center_classification_date": "20251104",
      "report_date": "20251112",
      "code_info": "a)  Lot # E410157, Exp Date: 12/2026; Lot # E407176, Exp Date: 08/2026; Lot # E405845, Exp Date: 06/2026; Lot # E400943, Exp Date: 01/2026 b)Lot # E410156, Exp Date: 12/2026; Lot # E400942, Exp Date: 01/2026 c) Lot # E410158, Exp Date: 12/2026; Lot # E407128, Exp Date: 08/2026; Lot # E405846, Exp Date: 06/2026; Lot # E400944, Exp Date: 01/2026",
      "more_code_info": ""
    }
  ]
}