{
  "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": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202164"
        ],
        "brand_name": [
          "PRAMIPEXOLE DIHYDROCHLORIDE"
        ],
        "generic_name": [
          "PRAMIPEXOLE DIHYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Macleods Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "33342-031",
          "33342-032",
          "33342-033",
          "33342-034",
          "33342-035"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PRAMIPEXOLE DIHYDROCHLORIDE"
        ],
        "rxcui": [
          "859033",
          "859040",
          "859044",
          "859048",
          "859052"
        ],
        "spl_id": [
          "721c81fc-fd21-4d86-ab96-9a329b8e015b"
        ],
        "spl_set_id": [
          "b8c94917-73a1-44c2-8fd8-07f45054176b"
        ],
        "package_ndc": [
          "33342-031-10",
          "33342-031-15",
          "33342-031-06",
          "33342-031-12",
          "33342-032-10",
          "33342-032-15",
          "33342-032-06",
          "33342-032-12",
          "33342-033-10",
          "33342-033-15",
          "33342-033-06",
          "33342-033-12",
          "33342-034-10",
          "33342-034-15",
          "33342-034-06",
          "33342-034-12",
          "33342-035-10",
          "33342-035-15",
          "33342-035-06",
          "33342-035-12"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0333342031105",
          "0333342035103",
          "0333342034106",
          "0333342033109",
          "0333342032102"
        ],
        "unii": [
          "3D867NP06J"
        ]
      },
      "product_type": "Drugs",
      "event_id": "73017",
      "recalling_firm": "Macleods Pharma Usa Inc",
      "address_1": "666 Plainsboro Rd",
      "address_2": "Bldg 200  Ste 230",
      "postal_code": "08536-3030",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0653-2016",
      "product_description": "Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.",
      "product_quantity": "N/A",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules:  Presence of a comingled Carbimazole 5 mg tablet.",
      "recall_initiation_date": "20151224",
      "center_classification_date": "20160205",
      "termination_date": "20200831",
      "report_date": "20160217",
      "code_info": "Lot #: BPA512A; Expiry: 06/2017.",
      "more_code_info": ""
    }
  ]
}