{
  "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": "71984",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-1378-2015",
      "product_description": "Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.",
      "product_quantity": "a) 16,848 and b) 216 Bottles",
      "reason_for_recall": "Subpotent Drug: Subpotent atorvastatin.",
      "recall_initiation_date": "20150813",
      "center_classification_date": "20150827",
      "termination_date": "20161215",
      "report_date": "20150902",
      "code_info": "a) Lot #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016"
    }
  ]
}