{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0555-2023.jsonld", "@type": "schema:Dataset", "name": "Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44", "description": "FDA recall D-0555-2023 — SCA Pharmaceuticals is recalling Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44 (Drugs, Class III). 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/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "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-0555-2023&lang=eng", "about": { "@type": "schema:Drug", "name": "Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44", "manufacturer": { "@type": "schema:Organization", "name": "SCA Pharmaceuticals" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0555-2023/enforcement-record", "@type": "schema:Claim", "name": "FDA recall D-0555-2023: SCA Pharmaceuticals is recalling Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44", "text": "The FDA logged enforcement record D-0555-2023: SCA Pharmaceuticals is voluntarily recalling Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44 — reason: Subpotent Drug: Out of specification results for low potency was obtained.. Status: Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.. Initiated 2023-04-10. Affected lots/codes: Lot # 1222043028 04/11/23 1222043029 04/13/23 1222043031 04/12/23 1222043032 04/12/23 1222043033 04/13/23 1222043034 04/13/23 1222043035 04/14/23 1222043036 04/14/23 1222043037 04/18/23 1222043038 04/18/23 1222043039 04/19/23 1222043040 04/19/23 1222043041 04/20/23 1222043042 04/20/23 1222043043 04/21/23 1222043044 04/21/23 1223041990 05/03/23 1223041991 05/03/23 1223041992 05/05/23 1223041993 05/06/23 1223041996 05/11/23 1223041997 05/10/23 1223041998 05/11/23 1223041999 05/12/23 1223042000 05/12/23 1223042001 05/13/23 1223042002 05/16/23 1223042003 05/17/23 1223042004 05/21/23 1223042006 05/16/23 1223042007 05/06/23 1223042008 05/10/23 1223042009 05/05/23 1223042010 05/04/23 1223042766 05/18/23 1223042767 05/17/23 1223042769 05/18/23 1223042770 05/19/23 1223042771 05/19/23 1223042772 05/20/23 1223042773 05/21/23 1223042774 05/23/23 1223042776 05/23/23 1223042777 05/24/23 1223042778 05/24/23 1223042783 05/31/23 1223042784 06/01/23 1223042785 05/31/23 1223042786 06/01/23 1223044081 06/02/23 1223044082 06/02/23 1223044117 06/06/23 1223044118 06/06/23 1223044143 06/03/23 1223044144 06/03/23 1223044166 06/14/23 1223044173 06/07/23 1223044191 06/07/23 1223044198 06/08/23 1223044220 06/08/23 1223044225 06/13/23 1223044247 06/14/23 1223044255 06/14/23 1223044267 06/15/23 1223044302 06/15/23 1223044311 06/16/23 1223044389 06/24/23 1223044523 06/24/23 1223044552 06/28/23 1223044582 06/27/23 1223044590 06/27/23 1223044629 06/29/23 1223044636 06/29/23 1223044656 06/30/23 1223044662 06/30/23 1223044682 07/01/23 1223044687 07/01/23 1223044711 07/05/23 1223044741 07/04/23 1223044749 07/04/23 1223044774 07/05/23 1223044793 07/06/23 1223044868 07/08/23. 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-0555-2023&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-0555-2023&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-0555-2023/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall D-0555-2023 as Class III", "text": "The FDA assigned this recall Class III: Class III — the FDA judged the product is unlikely to cause 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-0555-2023&lang=eng", "value": "Class III", "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-0555-2023&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-0555-2023/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-0555-2023", "numberOfItems": 10, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "D-0555-2023", "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 III", "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": "SCA Pharmaceuticals", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "Subpotent Drug: Out of specification results for low potency was obtained.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2023-04-10", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Terminated", "Value": "2023-09-20", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Lot/code info", "Value": "Lot # 1222043028 04/11/23 1222043029 04/13/23 1222043031 04/12/23 1222043032 04/12/23 1222043033 04/13/23 1222043034 04/13/23 1222043035 04/14/23 1222043036 04/14/23 1222043037 04/18/23 1222043038 04/18/23 1222043039 04/19/23 1222043040 04/19/23 1222043041 04/20/23 1222043042 04/20/23 1222043043 04/21/23 1222043044 04/21/23 1223041990 05/03/23 1223041991 05/03/23 1223041992 05/05/23 1223041993 05/06/23 1223041996 05/11/23 1223041997 05/10/23 1223041998 05/11/23 1223041999 05/12/23 1223042000 05/12/23 1223042001 05/13/23 1223042002 05/16/23 1223042003 05/17/23 1223042004 05/21/23 1223042006 05/16/23 1223042007 05/06/23 1223042008 05/10/23 1223042009 05/05/23 1223042010 05/04/23 1223042766 05/18/23 1223042767 05/17/23 1223042769 05/18/23 1223042770 05/19/23 1223042771 05/19/23 1223042772 05/20/23 1223042773 05/21/23 1223042774 05/23/23 1223042776 05/23/23 1223042777 05/24/23 1223042778 05/24/23 1223042783 05/31/23 1223042784 06/01/23 1223042785 05/31/23 1223042786 06/01/23 1223044081 06/02/23 1223044082 06/02/23 1223044117 06/06/23 1223044118 06/06/23 1223044143 06/03/23 1223044144 06/03/23 1223044166 06/14/23 1223044173 06/07/23 1223044191 06/07/23 1223044198 06/08/23 1223044220 06/08/23 1223044225 06/13/23 1223044247 06/14/23 1223044255 06/14/23 1223044267 06/15/23 1223044302 06/15/23 1223044311 06/16/23 1223044389 06/24/23 1223044523 06/24/23 1223044552 06/28/23 1223044582 06/27/23 1223044590 06/27/23 1223044629 06/29/23 1223044636 06/29/23 1223044656 06/30/23 1223044662 06/30/23 1223044682 07/01/23 1223044687 07/01/23 1223044711 07/05/23 1223044741 07/04/23 1223044749 07/04/23 1223044774 07/05/23 1223044793 07/06/23 1223044868 07/08/23", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 10, "item": { "Field": "Distribution pattern", "Value": "Nationwide in the USA", "Status": "recorded" } } ] } ] }