{
  "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": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA091133"
        ],
        "brand_name": [
          "BENZONATATE"
        ],
        "generic_name": [
          "BENZONATATE"
        ],
        "manufacturer_name": [
          "Strides Pharma Science Limited"
        ],
        "product_ndc": [
          "64380-712",
          "64380-713"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BENZONATATE"
        ],
        "rxcui": [
          "197397",
          "283417"
        ],
        "spl_id": [
          "21343425-d42f-4a46-ba47-30cedc9fe876"
        ],
        "spl_set_id": [
          "89f5d18e-5ef4-42a3-bc6f-abf4f308462b"
        ],
        "package_ndc": [
          "64380-712-06",
          "64380-712-07",
          "64380-713-06",
          "64380-713-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364380712077",
          "0364380712060",
          "0364380713074"
        ],
        "nui": [
          "N0000009010",
          "N0000175796"
        ],
        "pharm_class_pe": [
          "Decreased Tracheobronchial Stretch Receptor Activity [PE]"
        ],
        "pharm_class_epc": [
          "Non-narcotic Antitussive [EPC]"
        ],
        "unii": [
          "5P4DHS6ENR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77311",
      "recalling_firm": "Strides Pharma INC",
      "address_1": "2 Tower Center Blvd Ste 1102",
      "address_2": "",
      "postal_code": "08816-1100",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.A. Nationwide",
      "recall_number": "D-0858-2017",
      "product_description": "Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06",
      "product_quantity": "127,517 bottles",
      "reason_for_recall": "Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.",
      "recall_initiation_date": "20170509",
      "center_classification_date": "20170523",
      "termination_date": "20171222",
      "report_date": "20170531",
      "code_info": "Lot #: 7225075, 7225076, 7225077, 7225078, 7225079, 7225080 Exp 7/2017; 7225180, 7225181, 7225322, 7225323, Exp 8/2017; 7225649A, 7225650A , 7225651A , 7225652A, 7225653A, 7225654A, Exp 9/2017",
      "more_code_info": ""
    }
  ]
}