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  "name": "fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5",
  "description": "FDA recall D-1061-2023 — Central Admixture Pharmacy Services Inc is recalling fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5 (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1061-2023&lang=eng",
  "about": {
    "@type": "schema:Drug",
    "name": "fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5",
    "manufacturer": {
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      "name": "Central Admixture Pharmacy Services Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-1061-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall D-1061-2023: Central Admixture Pharmacy Services Inc is recalling fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5",
      "text": "The FDA logged enforcement record D-1061-2023: Central Admixture Pharmacy Services Inc is voluntarily recalling fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5 — reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles. Status: Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.. Initiated 2023-07-17. Affected lots/codes: Lot: 17-270584, 17-270586, 17-270597, 17-270613, Exp. 7/17/2023; 17-270655, 17-270659, 17-270741, Exp. 7/18/2023; 17-270872, 17-270875, Exp. 7/20/2023; 17-271040, 17-271041, 17-271042, 17-271058, 17-271066, 17-271071, 17-271080, Exp. 7/24/2023; 17-271111, 17-271148, 17-271150, 17-271151, 17-271152, 17-271166, Exp. 7/25/2023; 17-271241, 17-271267, Exp. 7/26/2023; 17-271402, 17-271407, 17-271413, 17-271429, Exp. 7/30/2023; 17-271555, 17-271556, 17-271560, 17-271594, Exp. 8/1/2023; 17-271754, Exp. 8/3/2023; 17-271797, 17-271799, 17-271821, 17-271842, Exp. 8/6/2023; 17-271888, 17-271889, Exp. 8/7/2023; 17-271949, 17-271950, Exp. 8/8/2023; 17-272021, 17-272041, Exp. 8/9/2023; 17-272285, 17-272292, 17-272309, 17-272316, Exp. 8/14/2023; 17-272705, 17-272708, 17-272709, 17-272722, 17-272725, Exp. 8/21/2023; 17-272784, 17-272810, Exp. 8/22/2023; 17-272916, Exp. 8/23/2023; 17-272981, 17-272982, 17-272983, 17-272984, Exp. 8/24/2023; 17-273144, 17-273145, 17-273158, 17-273159, 17-273165, Exp. 8/29/2023; 17-273480, 17-273485, 17-273492, 17-273494, 17-273498, Exp. 9/4/2023; 17-273567, 17-273568, 17-273578, 17-273603, Exp. 9/5/2023; 17-273767, 17-273777, 17-273781, Exp. 9/7/2023; 17-273980, Exp. 9/11/2023; 17-274130, 17-274135, Exp. 9/13/2023.. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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        "occurred": true,
        "supported": true,
        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1061-2023&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-1061-2023&lang=eng"
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      "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-1061-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall D-1061-2023 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
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-1061-2023&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-1061-2023/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": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — D-1061-2023",
      "numberOfItems": 10,
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            "Field": "Recall number",
            "Value": "D-1061-2023",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.",
            "Status": "recorded"
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          "item": {
            "Field": "Recalling firm",
            "Value": "Central Admixture Pharmacy Services Inc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Lack of assurance of sterility: Lack of validation data for sanitization cycles",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-07-17",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Terminated",
            "Value": "2025-03-21",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Lot/code info",
            "Value": "Lot: 17-270584, 17-270586, 17-270597, 17-270613, Exp. 7/17/2023; 17-270655, 17-270659, 17-270741, Exp. 7/18/2023; 17-270872, 17-270875, Exp. 7/20/2023; 17-271040, 17-271041, 17-271042, 17-271058, 17-271066, 17-271071, 17-271080, Exp. 7/24/2023; 17-271111, 17-271148, 17-271150, 17-271151, 17-271152, 17-271166, Exp. 7/25/2023; 17-271241, 17-271267, Exp. 7/26/2023; 17-271402, 17-271407, 17-271413, 17-271429, Exp. 7/30/2023; 17-271555, 17-271556, 17-271560, 17-271594, Exp. 8/1/2023; 17-271754, Exp. 8/3/2023; 17-271797, 17-271799, 17-271821, 17-271842, Exp. 8/6/2023; 17-271888, 17-271889, Exp. 8/7/2023; 17-271949, 17-271950, Exp. 8/8/2023; 17-272021, 17-272041, Exp. 8/9/2023; 17-272285, 17-272292, 17-272309, 17-272316, Exp. 8/14/2023; 17-272705, 17-272708, 17-272709, 17-272722, 17-272725, Exp. 8/21/2023; 17-272784, 17-272810, Exp. 8/22/2023; 17-272916, Exp. 8/23/2023; 17-272981, 17-272982, 17-272983, 17-272984, Exp. 8/24/2023; 17-273144, 17-273145, 17-273158, 17-273159, 17-273165, Exp. 8/29/2023; 17-273480, 17-273485, 17-273492, 17-273494, 17-273498, Exp. 9/4/2023; 17-273567, 17-273568, 17-273578, 17-273603, Exp. 9/5/2023; 17-273767, 17-273777, 17-273781, Exp. 9/7/2023; 17-273980, Exp. 9/11/2023; 17-274130, 17-274135, Exp. 9/13/2023.",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 10,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Nationwide in the USA",
            "Status": "recorded"
          }
        }
      ]
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}