{"url_path":"/fda/drug/recalls/D-0530-2026","section_key":"summary","section_title":"DRUG Recall: Huons Co., Ltd. — Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule),  NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 7…","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-0530-2026%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":107,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0530-2026\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\nBupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule),  NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)\n\n## Reason\nLack of Assurance of Sterility\n\n## Affected lots\nAll lots within expiry\n\n## Distribution\nUSA Nationwide."}