{"recall":{"id":"fda-drug-99262","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"McKesson recalls Gemcitabine Injection","firm":"McKesson","date":"2026-06-10","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01","code":"Lot #: CB0046, Exp. Date 06/2027","quantity":"74 units","number":"D-0714-2026","classification":"Class II"}],"reason":"Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide within the United States","nationwide":true,"states":[],"units":"74 units","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=99262","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c9d9a5e1d2ff366d","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","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=99262","record":[{"status":"Ongoing","city":"Irving","state":"TX","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA213175"],"brand_name":["GEMCITABINE"],"generic_name":["GEMCITABINE"],"manufacturer_name":["Hikma Pharmaceuticals USA Inc."],"product_ndc":["0143-9340","0143-9341","0143-9342"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["GEMCITABINE HYDROCHLORIDE"],"rxcui":["1720960","1720975","1720977"],"spl_id":["e9bd951d-0a47-409c-aa7c-2df9157d94e2"],"spl_set_id":["d80176fe-3e8b-48be-87c2-9c603013b3fa"],"package_ndc":["0143-9340-01","0143-9341-01","0143-9342-01"],"is_original_packager":[true],"unii":["U347PV74IL"]},"product_type":"Drugs","event_id":"99262","recalling_firm":"McKesson","address_1":"6555 State Highway 161","address_2":"N/A","postal_code":"75039-2402","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Telephone","distribution_pattern":"Nationwide within the United States","recall_number":"D-0714-2026","product_description":"Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922.  NDC: 0143-9341-01","product_quantity":"74  units","reason_for_recall":"Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.","recall_initiation_date":"20260610","center_classification_date":"20260721","report_date":"20260708","code_info":"Lot #: CB0046, Exp. Date 06/2027"}]}}