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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0380-2023.jsonld",
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  "name": "Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a)  30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.  Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA",
  "description": "FDA recall D-0380-2023 — Accord Healthcare, Inc. is recalling Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a)  30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.  Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA (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-0380-2023&lang=eng",
  "about": {
    "@type": "schema:Drug",
    "name": "Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a)  30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.  Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Accord Healthcare, Inc."
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0380-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall D-0380-2023: Accord Healthcare, Inc. is recalling Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a)  30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.  Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA",
      "text": "The FDA logged enforcement record D-0380-2023: Accord Healthcare, Inc. is voluntarily recalling Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a)  30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.  Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA — reason: CGMP Deviations: recalling drug products following an FDA inspection.. Status: Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.. Initiated 2023-02-07. Affected lots/codes: Batches: a) P2001925, Exp. Date 3/31/2023; P2003532, Exp. Date 6/30/2023; P2004847, Exp. Date 7/31/2023; R2000856, Exp. Date 11/30/2023; P2100452, Exp. Date 12/31/2023; P2100898, Exp. Date 1/31/2024; P2106273, Exp. Date 9/30/2024;   b) R2000578, Exp. Date 7/31/2023; R2000653, Exp. Date 9/30/2023; R2000652, Exp. Date 9/30/2023; R2000826, Exp. Date 10/31/2023; R2000852, Exp. Date 10/31/2023; R2000853, Exp. Date 10/31/2023; R2000827, Exp. Date 11/30/2023; P2100102, Exp. Date,12/31/2023; P2100004, Exp. Date 12/31/2023; P2100450, Exp. Date 12/31/2023; P2100449, Exp. Date 12/31/2023;  c)P2001392, P2001393, P2001395, P2001396, P2001397, P2001492, P2001493, P2001494, P2001495, Exp. Date 2/28/2023; P2001863, P2001864, P2001865, P2001924, P2001866, P2001926, P2001927, P2002072, P2002073, P2002071, P2002074, P2002075, P2002392, Exp. Date 3/31/2023; P2002230, P2002233, P2002234, P2002235, P2002274, P2002400, P2002399, P2002398, P2002479, P2002478, P2002481, P2002480, P2002482, P2002483, Exp. Date 4/30/2023; P2002759, P2002758, P2002755, P2002756, P2003058, P2003059, P2003061, P2003060, P2003062, P2003055, Exp. Date 5/31/2023; P2003533, P2003534, P2003535, P2003675, P2003537, P2003536, P2003676, P2003677, P2003678, P2003679, P2003680, P2003909, P2003910, Exp. Date 6/30/2023; P2004010, P2004008, P2004009, P2004232, P2004233, P2004234, Exp. Date 7/31/2023; P2004576, P2004838, R2000614, R2000624, R2000623, R2000615, R2000638, R2000637, R2000642, R2000640, Exp. Date 8/31/2023; R2000644, R2000662, R2000664, R2000643, R2000667, R2000666, R2000670, R2000671, R2000672, P2005692, P2005656, P2005693, P2005691, P2005694, Exp. Date 9/30/2023; P2005840, P2005841, P2005842, P2005843, P2005844, P2005870, P2005925, P2005923, P2005924, P2006007, P2006009, P2006010, P2005845, P2006008, P2006065, Exp. Date 10/31/2023; R2100003, R2100008, R2100010, R2100015, R2100016, R2100017, R2100018, R2100031, R2100022, R2100024, R2100069, R2100070, R2100071, R2100084, R2100080, R2100083, R2100078, R2100082, R2100093, Exp. Date 11/30/2023; P2100109, P2100304, P2100107, P2100103, P2100106, P2100108, P2100305, Exp. Date 12/31/2023; P2100718, P2100721, P2100720, P2100748, Exp. Date 1/31/2024; P2104140, Exp. Date 6/30/2024; P2104861, P2104860, P2104859, P2104866, Exp. Date 7/31/2024;. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
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        "occurred": true,
        "supported": true,
        "adjudged": true,
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      "grounding": {
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        "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-0380-2023&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-0380-2023&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-0380-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall D-0380-2023 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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      "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-0380-2023&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-0380-2023&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-0380-2023/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-0380-2023",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "D-0380-2023",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Drugs",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "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": "Accord Healthcare, Inc.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "CGMP Deviations: recalling drug products following an FDA inspection.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-02-07",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Terminated",
            "Value": "2024-04-22",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Lot/code info",
            "Value": "Batches: a) P2001925, Exp. Date 3/31/2023; P2003532, Exp. Date 6/30/2023; P2004847, Exp. Date 7/31/2023; R2000856, Exp. Date 11/30/2023; P2100452, Exp. Date 12/31/2023; P2100898, Exp. Date 1/31/2024; P2106273, Exp. Date 9/30/2024;   b) R2000578, Exp. Date 7/31/2023; R2000653, Exp. Date 9/30/2023; R2000652, Exp. Date 9/30/2023; R2000826, Exp. Date 10/31/2023; R2000852, Exp. Date 10/31/2023; R2000853, Exp. Date 10/31/2023; R2000827, Exp. Date 11/30/2023; P2100102, Exp. Date,12/31/2023; P2100004, Exp. Date 12/31/2023; P2100450, Exp. Date 12/31/2023; P2100449, Exp. Date 12/31/2023;  c)P2001392, P2001393, P2001395, P2001396, P2001397, P2001492, P2001493, P2001494, P2001495, Exp. Date 2/28/2023; P2001863, P2001864, P2001865, P2001924, P2001866, P2001926, P2001927, P2002072, P2002073, P2002071, P2002074, P2002075, P2002392, Exp. Date 3/31/2023; P2002230, P2002233, P2002234, P2002235, P2002274, P2002400, P2002399, P2002398, P2002479, P2002478, P2002481, P2002480, P2002482, P2002483, Exp. Date 4/30/2023; P2002759, P2002758, P2002755, P2002756, P2003058, P2003059, P2003061, P2003060, P2003062, P2003055, Exp. Date 5/31/2023; P2003533, P2003534, P2003535, P2003675, P2003537, P2003536, P2003676, P2003677, P2003678, P2003679, P2003680, P2003909, P2003910, Exp. Date 6/30/2023; P2004010, P2004008, P2004009, P2004232, P2004233, P2004234, Exp. Date 7/31/2023; P2004576, P2004838, R2000614, R2000624, R2000623, R2000615, R2000638, R2000637, R2000642, R2000640, Exp. Date 8/31/2023; R2000644, R2000662, R2000664, R2000643, R2000667, R2000666, R2000670, R2000671, R2000672, P2005692, P2005656, P2005693, P2005691, P2005694, Exp. Date 9/30/2023; P2005840, P2005841, P2005842, P2005843, P2005844, P2005870, P2005925, P2005923, P2005924, P2006007, P2006009, P2006010, P2005845, P2006008, P2006065, Exp. Date 10/31/2023; R2100003, R2100008, R2100010, R2100015, R2100016, R2100017, R2100018, R2100031, R2100022, R2100024, R2100069, R2100070, R2100071, R2100084, R2100080, R2100083, R2100078, R2100082, R2100093, Exp. Date 11/30/2023; P2100109, P2100304, P2100107, P2100103, P2100106, P2100108, P2100305, Exp. Date 12/31/2023; P2100718, P2100721, P2100720, P2100748, Exp. Date 1/31/2024; P2104140, Exp. Date 6/30/2024; P2104861, P2104860, P2104859, P2104866, Exp. Date 7/31/2024;",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 10,
          "item": {
            "Field": "Distribution pattern",
            "Value": "United States including Puerto Rico and Canada",
            "Status": "recorded"
          }
        }
      ]
    }
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}