{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irving",
      "state": "TX",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "BLA761039"
        ],
        "brand_name": [
          "UDENYCA"
        ],
        "generic_name": [
          "PEGFILGRASTIM-CBQV"
        ],
        "manufacturer_name": [
          "Accord BioPharma, Inc."
        ],
        "product_ndc": [
          "69448-025",
          "69448-026",
          "69448-027"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "PEGFILGRASTIM"
        ],
        "rxcui": [
          "2102703",
          "2102705",
          "2632544",
          "2632547",
          "2673598",
          "2673602"
        ],
        "spl_id": [
          "b9326155-8307-4ac1-9c13-6598e6c7a361"
        ],
        "spl_set_id": [
          "77a8576f-b91e-42ce-b613-2fa3c3d4a571"
        ],
        "package_ndc": [
          "69448-025-63",
          "69448-026-63",
          "69448-027-63"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369448025632"
        ],
        "nui": [
          "M0024696",
          "N0000009451",
          "N0000175666"
        ],
        "pharm_class_cs": [
          "Granulocyte Colony-Stimulating Factor [CS]"
        ],
        "pharm_class_pe": [
          "Increased Myeloid Cell Production [PE]"
        ],
        "pharm_class_epc": [
          "Leukocyte Growth Factor [EPC]"
        ],
        "unii": [
          "3A58010674"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98366",
      "recalling_firm": "McKesson",
      "address_1": "6555 State Highway 161",
      "address_2": "N/A",
      "postal_code": "75039-2402",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0353-2026",
      "product_description": "UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only,  Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63",
      "product_quantity": "116 cartons",
      "reason_for_recall": "Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.",
      "recall_initiation_date": "20260116",
      "center_classification_date": "20260226",
      "report_date": "20260218",
      "code_info": "Subset of Lot 2199821, Expires: 05/31/2027 Specific Serial Numbers being Recalled: 160R694TT06X; 1C74A686RPPG; 1W6A2M777N3V; 20825394KR8P; 242E2RK3EA92; 2DG49VH89EPG; 2WEA2ADK1P4H; 3KR2TVAG3VDH; 42M0V0G9PM84; 46E9XKDPTH1R; 4AM12WEAE48H; 4FGHR096DMNV; 4MWGWM991XNA; 4NEW8XD9DNM2; 4Y2PYDFN9YA1; 61EPX42R4K2A; 63FN9VW5CAV7; 69TG160DW2CV; 69XFP3TMTP7X; 6AWVDCNHTV61; 6CEFY72W5GPA; 6FHF1A59X0X4; 6GA64FNDVGXY; 6NW5FACPPWDW; 75V19CF2A0PA; 7HK7155YNAK3; 7R51VVA1WX9T; 7XCKXMH2EERC; 85D8MFVM66D4; 8F3Y5NFFHC64; 8RDWKPM53N5R; 8W1PVXC5NAFW; 9338DPED7P3R; 9A4CXFTGCPYN; 9FKN5NRDX99A; 9G79AR0RGAY4; 9K28G80GGYXN; 9NN7NXE40M13; A48PXEPE77YE; A8M168K58G64; AMR0RNWHTWMW; AR145NW8WTVX; AY19W6DEGRX4; C276HMDGRE49; CAY0ARAEGMCF; CKT370X2G4NP; D0DFAXCN6G5W; D54TXR8AD9Y8; DAK3XP1P3DMP; DH44AGKTX27F; E69E9K6C29VD; EK1D8P703RCH; EX947FYVW7Y6; F2K148YVNRDD; F4EVX8573F1V; FEXA7MENKWF1; FNDNMPAFH89D; G2W3WTMP5HK9; G5MN0F418FFY; G6XECANG6P01; G7FNVGWW3D72; GAHFFNX336GA; GKNTDP4AV6AA; GVPN5C4D23H6; GVPPYARK1FCD; GVXDAAA87GA1; GX7AP73W4HMH; HDTFT2W59K52; HDVG3W6VW59Y; HP703MKWGGM7; K8CGDV1301TP; KN6Y35T0A198; KVGC92YVC6XF; KYCP1Y7CK4R4; MEY2VW5MC0N9; MGH40F2679X3; N11XGETGDAVM; N9DGTY65NFGN; NH9VM1K2ECGP; NNCFT59RD1KF; NVFCXRWHX93N; P3XY0RNV0VPY; P609NH6W670V; P9Y7926YN82A; PA88CCXMWCMG; PKADTN18YR1X; PM0YHNNK6P4T; R11TYM5VE9CK; R45AXAEK4TTN; R6C3533P943P; RMW35MXX4R4K; RX75F9DA58W4; RXRCRP9272DG; RXTH041DMT5D; T2FW4C24F364; T442NHDFD7H8; TC3443DCR4F8; TK8TRR8NT92A; TT8K21TGYFWY; V255NE533X59; V6MYKEA7HN7P; V764DEYM4RYP; VCPTYV1EF0R1; VECGDTDV1Y3A; VEE09A07R9X5; VEER64AW2C51; VRN2TE3HPK5N; WF14WA03FNT2; WTP5TKRGNFGW; WWPMXV50FRM4; X1DKP0T2AE1W; X59C5AV3VDTG; XKG3T7811TD2; Y0CYY950EYK8; YCRW0EPK620Y; YNYA64T18DPW."
    }
  ]
}