{
  "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": "Holland",
      "state": "MI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA203690"
        ],
        "brand_name": [
          "CAREONE NICOTINE",
          "NICOTINE",
          "EQUATE NICOTINE",
          "NICOTINE MINI"
        ],
        "generic_name": [
          "NICOTINE POLACRILEX"
        ],
        "manufacturer_name": [
          "American Sales Company",
          "CVS Pharmacy",
          "Wal-Mart Stores Inc",
          "Walgreen Company"
        ],
        "product_ndc": [
          "41520-734",
          "59779-734",
          "49035-734",
          "0363-0734"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NICOTINE"
        ],
        "rxcui": [
          "359817"
        ],
        "spl_id": [
          "7e2a17fe-318d-4755-b48b-4d5bb1576288",
          "4a3989e0-911f-46c6-aa20-6b0a00d29509",
          "9e477213-5437-4b15-b165-24bc7c50520e",
          "cc25ea27-934e-4fdb-a806-77a8b5df2b89"
        ],
        "spl_set_id": [
          "74ec6a60-eb3a-47d4-a11b-650b6418d37f",
          "65ceb67b-dc22-4f5f-bfce-d6e957835eb3",
          "8c66eb21-dd95-4dcb-8488-e1e768dd8cd6",
          "95799f41-aa5c-4540-8b90-5f5ebe136332"
        ],
        "package_ndc": [
          "41520-734-02",
          "41520-734-03",
          "59779-734-01",
          "59779-734-02",
          "59779-734-52",
          "59779-734-60",
          "59779-734-04",
          "49035-734-01",
          "49035-734-03",
          "49035-734-04",
          "0363-0734-02",
          "0363-0734-04",
          "0363-0734-03",
          "0363-0734-05",
          "30142-734-02",
          "11822-0734-3",
          "11822-0734-2",
          "36800-734-60",
          "0363-0374-04",
          "11673-734-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0012345678905"
        ],
        "nui": [
          "N0000175706",
          "M0014836"
        ],
        "pharm_class_epc": [
          "Cholinergic Nicotinic Agonist [EPC]"
        ],
        "pharm_class_cs": [
          "Nicotine [CS]"
        ],
        "unii": [
          "6M3C89ZY6R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69048",
      "recalling_firm": "Perrigo Holland Inc",
      "address_1": "13295 Reflections Dr",
      "address_2": "N/A",
      "postal_code": "49424-8220",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.",
      "recall_number": "D-1558-2014",
      "product_description": "Nicotine Polacrilex Lozenge, 2 mg Mint Mini.  27 Ct Tubes, Over the Counter.  Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010.  Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons,  Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 0363-0734-02, 0363-0374-04, H) 20 Ct Stretchcard, Target Corporation, Minneapolis, MN 55403. NDC: 11673-734-02.",
      "product_quantity": "366,936 Tubes",
      "reason_for_recall": "Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.",
      "recall_initiation_date": "20140819",
      "center_classification_date": "20140822",
      "termination_date": "20150113",
      "report_date": "20140903",
      "code_info": "Cartons of 27 ct Tubes: Lot #: 2MV1074, Expiry: 09/14; Lot #: 2MV1124, Expiry: 09/14; Lot #: 2MV1142, Expiry: 09/14; Lot #: 2MV1143, Expiry: 09/14; Lot #: 3AV0528, Expiry: 09/14; Lot #: 3FV0575, Expiry: 09/14; Lot #: 3FV0535, Expiry: 03/15;   Lot #: 3FV0537, Expiry: 03/15; Lot #: 3FV0576, Expiry: 03/15; Lot #: 3FV0579, Expiry: 03/15; Lot #: 3FV0615, Expiry: 03/15;   Lot #: 3FV0739, Expiry: 03/15; Lot #: 3FV0742, Expiry: 03/15, Lot #: 3GV0713, Expiry: 03/15; Lot #: 3GV0715, Expiry: 03/15, Lot #: 3FV0421, Expiry: 03/15, Lot #: 3FV0422, Expiry: 03/15;   Lot #: 3FV0423, Expiry: 03/15; Lot #: 3FV0740, Expiry: 03/15.  20 Ct Stretchcard: Lot #: 3FV0520, Expiry: 03/15."
    }
  ]
}