{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0965-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1",
  "description": "FDA recall D-0965-2023 — Central Admixture Pharmacy Services, Inc. is recalling PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1 (Drugs, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0965-2023&lang=eng",
  "about": {
    "@type": "schema:Drug",
    "name": "PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Central Admixture Pharmacy Services, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0965-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall D-0965-2023: Central Admixture Pharmacy Services, Inc. is recalling PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1",
      "text": "The FDA logged enforcement record D-0965-2023: Central Admixture Pharmacy Services, Inc. is voluntarily recalling PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1 — reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.. Status: Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.. Initiated 2023-07-14. Affected lots/codes: Lot: 36-239063, 36-239064, 36-239065, 36-239066, 36-239067, 36-23906, 736-239068, 36-239069, 36-239204, Exp. 7/10/2023; 36-239196, 36-239197, 36-239198, 36-239199, 36-239200, 36-239201, 36-239202, 36-239203, 36-239205, 36-239206, Exp. 7/11/2023; 36-239483, 36-239487, 36-239488, 36-239489, 36-239490, 36-239639, 36-239640, 36-239641, Exp. 7/12/2023; 36-239788, 36-239789,36-239790, 36-239793, 36-239797, 36-239798, Exp. 7/13/2023; 36-240139, 36-240140, 36-240141, 36-240142, 36-240143, Exp. 7/16/2023; 36-240319, 36-240320, 36-240321 ,36-240322, 36-240812, Exp. 7/17/2023; 36-241074, 36-241075, 36-241076, 36-241077, Exp. 7/18/2023; 36-241136, Exp. 7/19/2023; 36-241357, 36-241358, 36-241359, 36-241372, 36-241373, Exp. 7/20/2023; 36-241715, 36-241718, 36-241719, 36-241720, 36-241721, 36-241723, 36-241850, Exp. 7/21/2023; 36-241918, 36-241919, 36-241920, 36-242184, Exp. 7/23/2023; 36-241993, 36-241994, 36-241995, 36-241997, Exp. 7/24/2023; 36-242402, 36-242403, 36-242404, 36-242405, 36-242406, 36-242913, Exp. 7/25/2023; 36-242630, 36-242631, 36-242632, 36-242633, 36-242634, Exp. 7/26/2023; 36-242799, 36-242800, 36-242801, 36-242802, 36-242803, 36-242806, Exp. 7/27/2023; 36-243537, 36-243538, 36-243539, Exp. 7/30/2023; 36-243820, 36-243822, 36-244311, 36-243819, Exp. 7/31/2023; 36-244877, 36-244878, 36-244879, 36-245572, 36-245574, Exp. 8/1/2023; 36-245805, 36-246140, 36-246141, 36-246142, 36-246143, Exp. 8/2/2023; 36-246292, 36-246293, 36-246294, 36-246295, 36-246296, 36-246297, Exp. 8/3/2023; 36-246696, 36-246697, 36-246700, 36-246702, Exp. 8/6/2023; 36-246780, 36-246781, 36-246782, 36-246784, 36-247058, Exp. 8/7/2023; 36-248214, 36-248217, 36-248223, 36-248230, 36-248235, Exp. 8/13/2023; 36-248996, 36-249236, Exp. 8/16/2023; 36-249321, 36-249322, 36-249323, Exp. 8/17/2023; 36-249516, 36-249517, Exp. 8/18/2023; 36-249737, 36-249741, 36-249742, 36-249743, 36-249744, 36-249745, Exp. 8/21/2023; 36-250073, 36-250075, 36-250076, Exp. 8/22/2023; 36-251191, 36-251192, 36-251193, Exp. 8/24/2023; 36-251611, 36-251612, Exp. 8/28/2023; 36-252326, 36-252328, Exp. 8/31/2023; 36-254328, 36-254330, 36-254334, Exp. 9/4/2023; 36-254948, 36-254949, 36-254950, 36-254951, 36-254952,  36-254954, 36-254955, Exp. 9/6/2023; 36-255633, 36-255635, 36-255636, Exp. 9/7/2023.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0965-2023&lang=eng",
        "value": "Drugs recall, status Terminated",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0965-2023&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0965-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall D-0965-2023 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0965-2023&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0965-2023&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0965-2023/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — D-0965-2023",
      "numberOfItems": 10,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "D-0965-2023",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Drugs",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Central Admixture Pharmacy Services, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Lack of assurance of sterility. Validation data for decontamination cycles is lacking.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-07-14",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Terminated",
            "Value": "2025-03-28",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Lot/code info",
            "Value": "Lot: 36-239063, 36-239064, 36-239065, 36-239066, 36-239067, 36-23906, 736-239068, 36-239069, 36-239204, Exp. 7/10/2023; 36-239196, 36-239197, 36-239198, 36-239199, 36-239200, 36-239201, 36-239202, 36-239203, 36-239205, 36-239206, Exp. 7/11/2023; 36-239483, 36-239487, 36-239488, 36-239489, 36-239490, 36-239639, 36-239640, 36-239641, Exp. 7/12/2023; 36-239788, 36-239789,36-239790, 36-239793, 36-239797, 36-239798, Exp. 7/13/2023; 36-240139, 36-240140, 36-240141, 36-240142, 36-240143, Exp. 7/16/2023; 36-240319, 36-240320, 36-240321 ,36-240322, 36-240812, Exp. 7/17/2023; 36-241074, 36-241075, 36-241076, 36-241077, Exp. 7/18/2023; 36-241136, Exp. 7/19/2023; 36-241357, 36-241358, 36-241359, 36-241372, 36-241373, Exp. 7/20/2023; 36-241715, 36-241718, 36-241719, 36-241720, 36-241721, 36-241723, 36-241850, Exp. 7/21/2023; 36-241918, 36-241919, 36-241920, 36-242184, Exp. 7/23/2023; 36-241993, 36-241994, 36-241995, 36-241997, Exp. 7/24/2023; 36-242402, 36-242403, 36-242404, 36-242405, 36-242406, 36-242913, Exp. 7/25/2023; 36-242630, 36-242631, 36-242632, 36-242633, 36-242634, Exp. 7/26/2023; 36-242799, 36-242800, 36-242801, 36-242802, 36-242803, 36-242806, Exp. 7/27/2023; 36-243537, 36-243538, 36-243539, Exp. 7/30/2023; 36-243820, 36-243822, 36-244311, 36-243819, Exp. 7/31/2023; 36-244877, 36-244878, 36-244879, 36-245572, 36-245574, Exp. 8/1/2023; 36-245805, 36-246140, 36-246141, 36-246142, 36-246143, Exp. 8/2/2023; 36-246292, 36-246293, 36-246294, 36-246295, 36-246296, 36-246297, Exp. 8/3/2023; 36-246696, 36-246697, 36-246700, 36-246702, Exp. 8/6/2023; 36-246780, 36-246781, 36-246782, 36-246784, 36-247058, Exp. 8/7/2023; 36-248214, 36-248217, 36-248223, 36-248230, 36-248235, Exp. 8/13/2023; 36-248996, 36-249236, Exp. 8/16/2023; 36-249321, 36-249322, 36-249323, Exp. 8/17/2023; 36-249516, 36-249517, Exp. 8/18/2023; 36-249737, 36-249741, 36-249742, 36-249743, 36-249744, 36-249745, Exp. 8/21/2023; 36-250073, 36-250075, 36-250076, Exp. 8/22/2023; 36-251191, 36-251192, 36-251193, Exp. 8/24/2023; 36-251611, 36-251612, Exp. 8/28/2023; 36-252326, 36-252328, Exp. 8/31/2023; 36-254328, 36-254330, 36-254334, Exp. 9/4/2023; 36-254948, 36-254949, 36-254950, 36-254951, 36-254952,  36-254954, 36-254955, Exp. 9/6/2023; 36-255633, 36-255635, 36-255636, Exp. 9/7/2023.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 10,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Nationwide in the USA",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}