{"recall":{"id":"fda-drug-100072","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Par Health USA, LLC recalls 2 products","firm":"Par Health USA, LLC","date":"2026-10-13","reported":"2026-10-28","status":"Ongoing","classification":"Class I","products":[{"name":"Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-182-01.","code":"Lot #: 83449, Exp Date: 10/2026; 82682, Exp Date: 11/2026; 86714, 87302, 87560, Exp Date: 02/2027; 87753, 88401, Exp Date: 03/2027; 88614, 88836, Exp Date: 04/2027; 90220, Exp Date: 05/2027; 91216, 91219, Exp Date: 06/2027; 92004, 92006, Exp Date: 07/2027; 92009, 92596, 92782, 93107, 93329, Exp Date: 08/2027; 93890, Exp Date: 09/2027.","quantity":"18,991 vials","number":"D-0082-2027","classification":"Class I"},{"name":"Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.","code":"Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027.","quantity":"1944 vials","number":"D-0083-2027","classification":"Class I"}],"reason":"Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Nationwide within the United States","nationwide":true,"states":[],"units":"18,991 vials; 1944 vials","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100072","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"2a23de04bc9ceb3a","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100072","record":[{"status":"Ongoing","city":"Rochester","state":"MI","country":"United States","classification":"Class I","openfda":{"application_number":["ANDA091665"],"brand_name":["ARGATROBAN"],"generic_name":["ARGATROBAN"],"manufacturer_name":["Par Health USA, LLC"],"product_ndc":["42023-182"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["ARGATROBAN"],"rxcui":["308351"],"spl_id":["05c8d32d-744b-4758-a94e-d912f410bbf7"],"spl_set_id":["d4e5238f-2378-424e-bda2-f1a2cf874041"],"package_ndc":["42023-182-01"],"is_original_packager":[true],"nui":["N0000175980","N0000175518","N0000009963"],"pharm_class_epc":["Anti-coagulant [EPC]","Direct Thrombin Inhibitor [EPC]"],"pharm_class_moa":["Thrombin Inhibitors [MoA]"],"unii":["IY90U61Z3S"]},"product_type":"Drugs","event_id":"100072","recalling_firm":"Par Health USA, LLC","address_1":"870 Parkdale Rd","address_2":"","postal_code":"48307-1740","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the United States","recall_number":"D-0082-2027","product_description":"Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only,  Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-182-01.","product_quantity":"18,991 vials","reason_for_recall":"Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.","recall_initiation_date":"20261013","center_classification_date":"20261026","report_date":"20261028","code_info":"Lot #: 83449, Exp Date: 10/2026; 82682, Exp Date: 11/2026; 86714, 87302, 87560, Exp Date: 02/2027; 87753, 88401, Exp Date: 03/2027; 88614, 88836, Exp Date: 04/2027; 90220, Exp Date: 05/2027; 91216, 91219, Exp Date: 06/2027; 92004, 92006, Exp Date: 07/2027; 92009, 92596, 92782, 93107, 93329, Exp Date: 08/2027; 93890, Exp Date: 09/2027.","more_code_info":""},{"status":"Ongoing","city":"Rochester","state":"MI","country":"United States","classification":"Class I","openfda":{"application_number":["ANDA091665"],"brand_name":["ARGATROBAN"],"generic_name":["ARGATROBAN"],"manufacturer_name":["Par Health USA, LLC"],"product_ndc":["42023-182"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["ARGATROBAN"],"rxcui":["308351"],"spl_id":["493ddc78-4566-486f-8cdd-7d6868ddf153"],"spl_set_id":["1a67a87d-59cb-414c-a11e-ab8f0a9bb778"],"package_ndc":["42023-182-89"],"is_original_packager":[true],"nui":["N0000175980","N0000175518","N0000009963"],"pharm_class_epc":["Anti-coagulant [EPC]","Direct Thrombin Inhibitor [EPC]"],"pharm_class_moa":["Thrombin Inhibitors [MoA]"],"unii":["IY90U61Z3S"]},"product_type":"Drugs","event_id":"100072","recalling_firm":"Par Health USA, LLC","address_1":"870 Parkdale Rd","address_2":"","postal_code":"48307-1740","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the United States","recall_number":"D-0083-2027","product_description":"Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.","product_quantity":"1944 vials","reason_for_recall":"Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.","recall_initiation_date":"20261013","center_classification_date":"20261026","report_date":"20261028","code_info":"Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027.","more_code_info":""}]}}