{
  "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": "North Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076557"
        ],
        "brand_name": [
          "LORATADINE AND PSEUDOEPHEDRINE SULFATE"
        ],
        "generic_name": [
          "LORATADINE AND PSEUDOEPHEDRINE SULFATE"
        ],
        "manufacturer_name": [
          "STRATEGIC SOURCING SERVICES"
        ],
        "product_ndc": [
          "49348-543"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORATADINE",
          "PSEUDOEPHEDRINE SULFATE"
        ],
        "rxcui": [
          "1117562"
        ],
        "spl_id": [
          "6459b34c-2237-4931-af7a-507effd2daf0"
        ],
        "spl_set_id": [
          "114b5e7c-973a-4a34-8538-a214de090b39"
        ],
        "package_ndc": [
          "49348-543-01",
          "49348-543-57",
          "0504280496",
          "0933511162",
          "30142-0724-69",
          "46122-0167-52",
          "37808-0724-69",
          "0118223315"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7AJO3BO7QN",
          "Y9DL7QPE6B"
        ],
        "upc": [
          "050428049631",
          "093351116285",
          "011822331555"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67631",
      "recalling_firm": "Ohm Laboratories, Inc.",
      "address_1": "1385 Livingston Ave",
      "address_2": "N/A",
      "postal_code": "08902-1829",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "CA OH, PA, RI,& TX",
      "recall_number": "D-1256-2014",
      "product_description": "Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, 5-count box  Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02805 UPC 050428049631    B) Discount Drug Mart Non-Drowsy 24 Hour Formula  Allergy Relief and Nasal Decongestant, Loratadine, USP 10 mg/Antihistamine Pseudephrine Sulfate, USP 240 mg/Nasal Decongestant  Extended Release Tablets, 15-count box  Distributed by Drug Mart-Food Fair Medina, Ohio 44256 UPC 093351116285    C) Kroger Non-Drowsy Allergy and Congestion Loratadine and Pseudoephedrine Extended Release Tablets  Pseudoephedrine Sulfate, USP 240 mg Nasal Decongestant  Loratadine, USP 10 mg, Antihistamine 10- count box, Distributed by The Kroger Co., Cincinnati, Ohio 45202  NDC 30142-0724-69.    D) Sunmark Allergy & Congestion Lorata*dine D Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, Indoor & Outdoor Allergies, Non-Drowsy 10- count box, Distributed by Mckesson One Post Street, San Francisco, CA 94104 NDC 49348-543-01    E) Good Neighbor Pharmacy  Non-Drowsy Allergy and Congestion Relief  pseudoephedrine sulfate, USP 240 mg/nasal decongestant loratadine, USP 10 mg/antihistamine Indoor & Outdoor Allergies Extended-Release Tablets, 10- count box, Distributed by Amerisource Bergen 1300 Morris Drive, Chesterbrook, PA 19087 NDC46122-0167-52    F) H-E-B Allergy Relief - D Non-Drowsy- 24 Hour Formula Loratadine, USP 10mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decogestant Indoor & Outdoor Allegies, Allergy & Congestion Extended-Release Tablets 10-count box, Distributed by H-E-B San Antonio, TX 78204    NDC 37808-0724-69    G) Rite Aid Pharmacy allergy relief & nasal decongestant loratadine USP, 10 mg, pseudoephedribe sulfate USP, 240 mg, antihistamine & nasal degestant,  extended release tablets, 10- count box,  Distributed by: Rite Aid 30 Hunter Lane Camp Hill, PA 17011   UPC 0118223315555",
      "product_quantity": "29,790 blister packs",
      "reason_for_recall": "Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.",
      "recall_initiation_date": "20140207",
      "center_classification_date": "20140423",
      "termination_date": "20150501",
      "report_date": "20140430",
      "code_info": "Lot # 2554936, 2554938; Exp 09/15",
      "more_code_info": ""
    }
  ]
}