{"url_path":"/fda/drug/recalls/D-0714-2026","section_key":"summary","section_title":"DRUG Recall: McKesson — 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","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-06-10","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0714-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"McKesson"},"word_count":97,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0714-2026\n\n**Recalling firm:** McKesson\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-10\n**Report date:** 2026-07-08\n\n## Product\nGemcitabine 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\n\n## Reason\nTemperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.\n\n## Affected lots\nLot #: CB0046, Exp. Date 06/2027\n\n## Distribution\nNationwide within the United States"}