Lack of Assurance of Sterility
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact Chiesi USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.. Generic: PORACTANT ALFA; Brand: CUROSURF. Reason: Lack of Assurance of Sterility. Classification: Class II. Quantity: 7,235 vials. Distribution: Nationwide within the United States
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Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Failed tablet specifications.
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Product labeling includes a fetal indication for use that is not cleared under its 510(k).