{
  "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": "Oklahoma City",
      "state": "OK",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090295"
        ],
        "brand_name": [
          "METFORMIN HYDROCHLORIDE EXTENDED RELEASE"
        ],
        "generic_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "PD-Rx Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "72789-009"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "860975"
        ],
        "spl_id": [
          "3143f509-5529-ee8b-e063-6294a90aeed3"
        ],
        "spl_set_id": [
          "14f3091c-f243-4364-b433-727c7d4ef8d5"
        ],
        "package_ndc": [
          "72789-009-30",
          "72789-009-60",
          "72789-009-90",
          "72789-009-93",
          "49483-0623-01"
        ],
        "original_packager_product_ndc": [
          "49483-623"
        ],
        "unii": [
          "786Z46389E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "85828",
      "recalling_firm": "PD-Rx Pharmaceuticals, Inc.",
      "address_1": "727 N Ann Arbor Ave",
      "address_2": "N/A",
      "postal_code": "73127-5822",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "United States.",
      "recall_number": "D-1333-2020",
      "product_description": "metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01)  bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127",
      "product_quantity": "1969 bottles",
      "reason_for_recall": "CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level",
      "recall_initiation_date": "20200605",
      "center_classification_date": "20200620",
      "termination_date": "20211108",
      "report_date": "20200701",
      "code_info": "Lots:  a) A20B02, I19D03, J19A98, K19E32, L19C86 Exp. 12/31/2020;     b) I19D55, I19F50, K19A18, K19D87, L19B34, L19D23, L19E74 Exp. 12/31/2020;     c) I19E91, I19F33, J19B88, J19E70, K19D26, L19A65 Exp. 12/31/2020;     d) I19C21 Exp. 08/21/2020, I19C57, J19C21, J19C67, K19B53, L19C77, L19E44 Exp. 12/31/2020;     e) XP9004 Exp. 12/31/2020"
    }
  ]
}