{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA203874"
        ],
        "brand_name": [
          "AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM"
        ],
        "generic_name": [
          "AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Inc"
        ],
        "product_ndc": [
          "43598-313",
          "43598-323",
          "43598-320",
          "43598-317",
          "43598-322",
          "43598-319",
          "43598-316",
          "43598-314",
          "43598-321",
          "43598-318",
          "43598-315"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMLODIPINE BESYLATE",
          "ATORVASTATIN CALCIUM TRIHYDRATE"
        ],
        "rxcui": [
          "404011",
          "404013",
          "597967",
          "597971",
          "597974",
          "597977",
          "597980",
          "597984",
          "597987",
          "597990",
          "597993"
        ],
        "spl_id": [
          "54058ac6-94e2-d2d3-5c46-886b3478fc76"
        ],
        "spl_set_id": [
          "abee4a34-89cc-d886-192c-32582ab8f024"
        ],
        "package_ndc": [
          "43598-323-30",
          "43598-323-60",
          "43598-323-90",
          "43598-323-05",
          "43598-320-30",
          "43598-320-60",
          "43598-320-90",
          "43598-320-05",
          "43598-317-30",
          "43598-317-60",
          "43598-317-90",
          "43598-317-05",
          "43598-322-30",
          "43598-322-60",
          "43598-322-90",
          "43598-322-05",
          "43598-319-30",
          "43598-319-60",
          "43598-319-90",
          "43598-319-05",
          "43598-316-30",
          "43598-316-60",
          "43598-316-90",
          "43598-316-05",
          "43598-314-30",
          "43598-314-60",
          "43598-314-90",
          "43598-314-05",
          "43598-321-30",
          "43598-321-60",
          "43598-321-90",
          "43598-321-05",
          "43598-318-30",
          "43598-318-60",
          "43598-318-90",
          "43598-318-05",
          "43598-315-30",
          "43598-315-60",
          "43598-315-90",
          "43598-315-05",
          "43598-313-30",
          "43598-313-60",
          "43598-313-90",
          "43598-313-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343598323305",
          "0343598315300",
          "0343598320304",
          "0343598317304",
          "0343598313306",
          "0343598322308",
          "0343598319308",
          "0343598316307",
          "0343598314303"
        ],
        "unii": [
          "864V2Q084H",
          "48A5M73Z4Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71375",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1144-2015",
      "product_description": "Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India",
      "product_quantity": "",
      "reason_for_recall": "Subpotent drug",
      "recall_initiation_date": "20150506",
      "center_classification_date": "20150618",
      "termination_date": "20160331",
      "report_date": "20150624",
      "code_info": "Lot #: a) C401537, Exp 07/2015; b) C401539, Exp 07/2015",
      "more_code_info": ""
    }
  ]
}