enforcement_detail.json•1.72 kB
{
"meta": {
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"results": [
{
"country": "United States",
"city": "Princeton",
"reason_for_recall": "Presence of N-Nitrosodimethylamine (NDMA) impurity above the acceptable daily intake limit",
"address_1": "One Merck Drive",
"address_2": "Building 5",
"product_quantity": "5,432 bottles",
"code_info": "Lot numbers: AB1234 (Exp 12/2024), CD5678 (Exp 01/2025), EF9012 (Exp 02/2025)",
"center_classification_date": "20230615",
"distribution_pattern": "Nationwide distribution to wholesalers and retail pharmacies in all 50 states",
"state": "NJ",
"product_description": "Valsartan Tablets USP, 160 mg, 90 count bottles, NDC 0378-5160-90",
"report_date": "20230622",
"classification": "Class II",
"openfda": {
"application_number": ["ANDA090802"],
"brand_name": ["VALSARTAN"],
"generic_name": ["VALSARTAN"],
"manufacturer_name": ["Mylan Pharmaceuticals Inc."],
"product_ndc": ["0378-5160"],
"package_ndc": ["0378-5160-90"],
"unii": ["80M03YXJ7I"],
"spl_set_id": ["4b5c5f6d-7e8f-9g0h-1i2j-3k4l5m6n7o8p"]
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"more_code_info": "Manufacturing dates: January 2023 - March 2023",
"recalling_firm": "Mylan Pharmaceuticals Inc.",
"recall_number": "D-0001-2023",
"initial_firm_notification": "Letter",
"product_type": "Drugs",
"event_id": "91234",
"termination_date": "",
"recall_initiation_date": "20230610",
"postal_code": "08540-0004",
"voluntary_mandated": "Voluntary: Firm Initiated",
"status": "Ongoing"
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