{
  "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": "2026-06-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bedminster",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA204453"
        ],
        "brand_name": [
          "MINOCYCLINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "MINOCYCLINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-436",
          "67877-578",
          "67877-576",
          "67877-577",
          "67877-643",
          "67877-644",
          "67877-437",
          "67877-438"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MINOCYCLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "629695",
          "629697",
          "629699",
          "858062",
          "858372",
          "1013659",
          "1013662",
          "1013665"
        ],
        "spl_id": [
          "51213aa1-873c-4b55-a36d-3ebbb73fa220"
        ],
        "spl_set_id": [
          "a8f95207-b259-4f50-87f2-3652d9268890"
        ],
        "package_ndc": [
          "67877-578-14",
          "67877-578-30",
          "67877-578-01",
          "67877-578-05",
          "67877-576-14",
          "67877-576-30",
          "67877-576-01",
          "67877-576-05",
          "67877-577-14",
          "67877-577-30",
          "67877-577-01",
          "67877-577-05",
          "67877-643-14",
          "67877-643-30",
          "67877-643-01",
          "67877-643-05",
          "67877-644-14",
          "67877-644-30",
          "67877-644-01",
          "67877-644-05",
          "67877-436-14",
          "67877-436-30",
          "67877-436-01",
          "67877-436-05",
          "67877-437-14",
          "67877-437-30",
          "67877-437-01",
          "67877-437-05",
          "67877-438-14",
          "67877-438-30",
          "67877-438-01",
          "67877-438-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "0020414E5U"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99129",
      "recalling_firm": "Ascend Laboratories, LLC",
      "address_1": "135 Us Highway 202 206 Ste 15",
      "address_2": "N/A",
      "postal_code": "07921-2608",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0597-2026",
      "product_description": "Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.  NDC: 67877-644-30",
      "product_quantity": "360 30-count bottles",
      "reason_for_recall": "Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis",
      "recall_initiation_date": "20260601",
      "center_classification_date": "20260617",
      "report_date": "20260617",
      "code_info": "Lot#  25141635, Exp 4/30/2028"
    }
  ]
}