{"url_path":"/fda/drug/recalls/D-0531-2026","section_key":"summary","section_title":"DRUG Recall: Huons Co., Ltd. — 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-02","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0531-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Huons Co., Ltd."},"word_count":76,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0531-2026\n\n**Recalling firm:** Huons Co., Ltd.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-02\n**Report date:** 2026-04-22\n\n## Product\n0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.\n\n## Reason\nLack of Assurance of Sterility\n\n## Affected lots\nAll lots within expiry\n\n## Distribution\nUSA Nationwide."}