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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0576-2023.jsonld",
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  "name": "LORazepam Injection, 2mg / mL  Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00",
  "description": "FDA recall D-0576-2023 — RemedyRepack Inc. is recalling LORazepam Injection, 2mg / mL  Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00 (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/",
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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": {
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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-0576-2023&lang=eng",
  "about": {
    "@type": "schema:Drug",
    "name": "LORazepam Injection, 2mg / mL  Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00",
    "manufacturer": {
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      "name": "RemedyRepack Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0576-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall D-0576-2023: RemedyRepack Inc. is recalling LORazepam Injection, 2mg / mL  Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00",
      "text": "The FDA logged enforcement record D-0576-2023: RemedyRepack Inc. is voluntarily recalling LORazepam Injection, 2mg / mL  Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00 — reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.. Status: Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.. Initiated 2023-05-01. Affected lots/codes: Lot # B2169656-032223, B2169663-032223, B2169680-032223, B2169713-032223, B2109085-021423, B2109094-021423, B2049229-010623, B2049235-010623, Exp. Date 04/30/2025; B2049224-010623, B2027905-122222, B2027920-122222, B2027941-122222, B2027968-122222, B2027979-122222, B2027989-122222, B2005343-120922, B2005333-120922, Exp. Date 03/31/2025; B1970782-112122, Exp. Date 01/31/2025; B1878510-092922, Exp. Date 11/30/2024; B1904609-101322, B1866210-092222, Exp. Date 12/31/2024; B1711316-060222, B1711328-060222, Exp. Date 09/30/2024; B1660244-042522, Exp. Date 07/31/2024; B1660288-042522, B1617673-032422, Exp. Date 06/30/2024; B1617737-032422, B1617744-032422, B1563407-021422, B1563498-021422, Exp. Date 05/31/2024; B1539158-012822, B1518050-011222, B1498175-122921, Exp. Date 04/30/2024; B1498194-122921, B1455889-112621, B1455918-112621, Exp. Date 03/31/2024; B1455901-112621, B1396346-101421, B1383216-100721, Exp. Date 01/31/2024; B1383214-100721, B1353451-091721, B1353463-091721, B1353480-091721, B1274069-071521, B1274079-071521, B1274052-071521, B1234313-061721, B1234339-061721, B1203592-052721, B1203608-052721, B1163740-042921, Exp. Date 09/30/2023; B1163745-042921, B1163747-042921, B1140139-040821, Exp. Date 05/31/2023.. A RECORDED FDA enforcement action (occurred=true).",
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        "occurred": true,
        "supported": true,
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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-0576-2023&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-0576-2023&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-0576-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall D-0576-2023 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": {
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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-0576-2023&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-0576-2023/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
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      "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-0576-2023",
      "numberOfItems": 10,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "D-0576-2023",
            "Status": "recorded"
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          "item": {
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            "Value": "Drugs",
            "Status": "recorded"
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            "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"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "RemedyRepack Inc.",
            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-01",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Terminated",
            "Value": "2023-06-21",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Lot/code info",
            "Value": "Lot # B2169656-032223, B2169663-032223, B2169680-032223, B2169713-032223, B2109085-021423, B2109094-021423, B2049229-010623, B2049235-010623, Exp. Date 04/30/2025; B2049224-010623, B2027905-122222, B2027920-122222, B2027941-122222, B2027968-122222, B2027979-122222, B2027989-122222, B2005343-120922, B2005333-120922, Exp. Date 03/31/2025; B1970782-112122, Exp. Date 01/31/2025; B1878510-092922, Exp. Date 11/30/2024; B1904609-101322, B1866210-092222, Exp. Date 12/31/2024; B1711316-060222, B1711328-060222, Exp. Date 09/30/2024; B1660244-042522, Exp. Date 07/31/2024; B1660288-042522, B1617673-032422, Exp. Date 06/30/2024; B1617737-032422, B1617744-032422, B1563407-021422, B1563498-021422, Exp. Date 05/31/2024; B1539158-012822, B1518050-011222, B1498175-122921, Exp. Date 04/30/2024; B1498194-122921, B1455889-112621, B1455918-112621, Exp. Date 03/31/2024; B1455901-112621, B1396346-101421, B1383216-100721, Exp. Date 01/31/2024; B1383214-100721, B1353451-091721, B1353463-091721, B1353480-091721, B1274069-071521, B1274079-071521, B1274052-071521, B1234313-061721, B1234339-061721, B1203592-052721, B1203608-052721, B1163740-042921, Exp. Date 09/30/2023; B1163745-042921, B1163747-042921, B1140139-040821, Exp. Date 05/31/2023.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 10,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Product was distrituded to three direct account in PA.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}