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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-1066-2023.jsonld",
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  "name": "PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1",
  "description": "FDA recall D-1066-2023 — Central Admixture Pharmacy Services Inc is recalling PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1 (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.",
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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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      "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-1066-2023&lang=eng",
  "about": {
    "@type": "schema:Drug",
    "name": "PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Central Admixture Pharmacy Services Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-1066-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall D-1066-2023: Central Admixture Pharmacy Services Inc is recalling PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1",
      "text": "The FDA logged enforcement record D-1066-2023: Central Admixture Pharmacy Services Inc is voluntarily recalling PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1 — 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: 17-270449, 17-270450, 17-270453, 17-270462, 17-270465, 17-270466, 17-270494, 17-270495, 17-270502, 17-270541, Exp. 7/16/2023; 17-270582, 17-270585, 17-270587, 17-270592, 17-270593, 17-270598, 17-270610, 17-270611, 17-270612, Exp. 7/17/2023; 17-270900, 17-270902, 17-270906, 17-270907, 17-270908, 17-270909, 17-270953, 17-270955, 17-270991, 17-270993, Exp. 7/23/2023; 17-271047, 17-271048, 17-271050, 17-271053, Exp. 7/24/2023; 17-271344, 17-271349, 17-271355, 17-271356, 17-271405, 17-271406, Exp. 7/31/2023; 17-271478, 17-271479, 17-271480, 17-271484, 17-271495, 17-271500, Exp. 7/31/2023; 17-271744, 17-271763, Exp. 8/3/2023; 17-271838, 17-271851, Exp. 8/6/2023; 17-271871, 17-271873, 17-271886, 17-271887, 17-271892, 17-271899, 17-271900, 17-271901, 17-271902, Exp. 8/7/2023; 17-272067, 17-272068, 17-272069, 17-272095, Exp. 8/9/2023; 17-272102, 17-272141, 17-272142, Exp. 8/10/2023; 17-272205, 17-272235, 17-272237, 17-272240, 17-272242, Exp. 8/13/2023; 17-272307, 17-272308, Exp. 8/14/2023; 17-272391, 17-272392, 17-272395, Exp. 8/15/2023; 17-272472, Exp. 8/16/2023; 17-272538, Exp. 8/17/2023; 17-272558, 17-272560, 17-272564, 17-272593, 17-272594, 17-272618, 17-272619, 17-272651, 17-272653, 17-272680, Exp. 8/20/2023; 17-272697, 17-272727, 17-272729, Exp. 8/21/2023; 17-272775, 17-272791, 17-272820, 17-272821, Exp. 8/22/2023; 17-272904, 17-272918, 17-272919, 17-272920, 17-272921, 17-272929, Exp. 8/23/2023; 17-272930, 17-272974, 17-272993, 17-272994, 17-272995, 17-272996, Exp. 8/24/2023; 17-272999, 17-273003, 17-273004, 17-273005, 17-273006, 17-273007, Exp. 8/27/2023; 17-273080, Exp. 8/28/2023; 17-273151, 17-273175, 17-273176, 17-273185, Exp. 8/29/2023; 17-273252, 17-273265, 17-273266, Exp. 8/30/2023; 17-273345, 17-273351, 17-273352, 17-273355, 17-273356, 17-273358, 17-273359, 17-273360, Exp. 8/31/2023; 17-273402, 17-273408, 17-273416, 17-273440, 17-273441, 17-273447, Exp. 9/3/2023; 17-273487, 17-273488, 17-273489, 17-273490, 17-273491, 17-273499, 17-273510, 17-273516, Exp. 9/4/2023; 17-273587, 17-273589, 17-273596, 17-273597, 17-273610, 17-273614, 17-273666, Exp. 9/5/2023; 17-273617, 17-273665, 17-273703, 17-273704, 17-273713, 17-273714, 17-273720, 17-273721, 17-273730, 17-273737, 17-273739, Exp. 9/6/2023; 17-273773, Exp. 9/7/2023; 17-273802, 17-273803, 17-273808, 17-273809, 17-273815, 17-273848, 17-273869, 17-273874, 17-273880, 17-273881, 17-273893, Exp. 9/10/2023; 17-273903, 17-273958, 17-273960, 17-273961, 17-273964, 17-273965, Exp. 9/11/2023.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-1066-2023&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-1066-2023&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-1066-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall D-1066-2023 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-1066-2023&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-1066-2023&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-1066-2023/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."
    }
  ],
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      "name": "FDA recall details — D-1066-2023",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "D-1066-2023",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Drugs",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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        {
          "@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: Lack of validation data for sanitization cycles",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-07-17",
            "Status": "recorded"
          }
        },
        {
          "@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: 17-270449, 17-270450, 17-270453, 17-270462, 17-270465, 17-270466, 17-270494, 17-270495, 17-270502, 17-270541, Exp. 7/16/2023; 17-270582, 17-270585, 17-270587, 17-270592, 17-270593, 17-270598, 17-270610, 17-270611, 17-270612, Exp. 7/17/2023; 17-270900, 17-270902, 17-270906, 17-270907, 17-270908, 17-270909, 17-270953, 17-270955, 17-270991, 17-270993, Exp. 7/23/2023; 17-271047, 17-271048, 17-271050, 17-271053, Exp. 7/24/2023; 17-271344, 17-271349, 17-271355, 17-271356, 17-271405, 17-271406, Exp. 7/31/2023; 17-271478, 17-271479, 17-271480, 17-271484, 17-271495, 17-271500, Exp. 7/31/2023; 17-271744, 17-271763, Exp. 8/3/2023; 17-271838, 17-271851, Exp. 8/6/2023; 17-271871, 17-271873, 17-271886, 17-271887, 17-271892, 17-271899, 17-271900, 17-271901, 17-271902, Exp. 8/7/2023; 17-272067, 17-272068, 17-272069, 17-272095, Exp. 8/9/2023; 17-272102, 17-272141, 17-272142, Exp. 8/10/2023; 17-272205, 17-272235, 17-272237, 17-272240, 17-272242, Exp. 8/13/2023; 17-272307, 17-272308, Exp. 8/14/2023; 17-272391, 17-272392, 17-272395, Exp. 8/15/2023; 17-272472, Exp. 8/16/2023; 17-272538, Exp. 8/17/2023; 17-272558, 17-272560, 17-272564, 17-272593, 17-272594, 17-272618, 17-272619, 17-272651, 17-272653, 17-272680, Exp. 8/20/2023; 17-272697, 17-272727, 17-272729, Exp. 8/21/2023; 17-272775, 17-272791, 17-272820, 17-272821, Exp. 8/22/2023; 17-272904, 17-272918, 17-272919, 17-272920, 17-272921, 17-272929, Exp. 8/23/2023; 17-272930, 17-272974, 17-272993, 17-272994, 17-272995, 17-272996, Exp. 8/24/2023; 17-272999, 17-273003, 17-273004, 17-273005, 17-273006, 17-273007, Exp. 8/27/2023; 17-273080, Exp. 8/28/2023; 17-273151, 17-273175, 17-273176, 17-273185, Exp. 8/29/2023; 17-273252, 17-273265, 17-273266, Exp. 8/30/2023; 17-273345, 17-273351, 17-273352, 17-273355, 17-273356, 17-273358, 17-273359, 17-273360, Exp. 8/31/2023; 17-273402, 17-273408, 17-273416, 17-273440, 17-273441, 17-273447, Exp. 9/3/2023; 17-273487, 17-273488, 17-273489, 17-273490, 17-273491, 17-273499, 17-273510, 17-273516, Exp. 9/4/2023; 17-273587, 17-273589, 17-273596, 17-273597, 17-273610, 17-273614, 17-273666, Exp. 9/5/2023; 17-273617, 17-273665, 17-273703, 17-273704, 17-273713, 17-273714, 17-273720, 17-273721, 17-273730, 17-273737, 17-273739, Exp. 9/6/2023; 17-273773, Exp. 9/7/2023; 17-273802, 17-273803, 17-273808, 17-273809, 17-273815, 17-273848, 17-273869, 17-273874, 17-273880, 17-273881, 17-273893, Exp. 9/10/2023; 17-273903, 17-273958, 17-273960, 17-273961, 17-273964, 17-273965, Exp. 9/11/2023.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 10,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Nationwide in the USA",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}