{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA012462"
        ],
        "brand_name": [
          "DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE"
        ],
        "generic_name": [
          "DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "59762-1061"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATROPINE SULFATE",
          "DIPHENOXYLATE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1190572"
        ],
        "spl_id": [
          "b4b0055f-415c-49fa-9c67-cc600ac024be"
        ],
        "spl_set_id": [
          "83bcc2fb-6fb0-4f0e-8e66-592d327684ec"
        ],
        "package_ndc": [
          "59762-1061-1",
          "59762-1061-2"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359762106117"
        ],
        "unii": [
          "03J5ZE7KA5",
          "W24OD7YW48"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78332",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 E 42nd St",
      "address_2": "N/A",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0150-2018",
      "product_description": "diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg,  a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977",
      "product_quantity": "183437 bottles",
      "reason_for_recall": "SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent",
      "recall_initiation_date": "20171020",
      "center_classification_date": "20180104",
      "termination_date": "20200602",
      "report_date": "20180110",
      "code_info": "Lots: a) R83962, R93347, R93348, R93349, R93350, R93351, R93352, Exp. 2021 OCT 31; S57831, S57832, S57834, Exp. 2021 NOV 30 b) R93356, R93357, R93358, R97310, Exp. 2021 OCT 31."
    }
  ]
}