{"url_path":"/fda/drug/recalls/D-0490-2026","section_key":"summary","section_title":"DRUG Recall: Premier Dental Products Co — Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-14","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0490-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Premier Dental Products Co"},"word_count":122,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0490-2026\n\n**Recalling firm:** Premier Dental Products Co\n**Classification:** Class III\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-14\n**Report date:** 2026-04-29\n\n## Product\nPremier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.\n\n## Reason\nLabeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.\n\n## Affected lots\nLot #: 640911253, Exp Date. 09/14/2027.\n\n## Distribution\nNationwide within the United States"}