{"url_path":"/fda/drug/recalls/D-0838-2026","section_key":"summary","section_title":"DRUG Recall: Chiesi USA, Inc. — Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518,  NDC 10122-502-01","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-08-19","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0838-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Chiesi USA, Inc."},"word_count":76,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0838-2026\n\n**Recalling firm:** Chiesi USA, Inc.\n**Classification:** Class III\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-08-19\n**Report date:** 2026-09-09\n\n## Product\nRevcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518,  NDC 10122-502-01\n\n## Reason\nFailed Stability Specifications: Out of specification stability result for the protein concentration profile.\n\n## Affected lots\nLot#: 1221973, Exp 3/24/2027\n\n## Distribution\nMO, TN"}