Houston Rx LLC — Class II: Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC
Houston Rx LLC has initiated a Class II recall for Tirzepatide/Niacinamide 2mL injection vials (40 MG per vial) due to a lack of assurance of sterility. The recall is currently classified as ongoing by the FDA.
This recall affects Houston Rx LLC, healthcare providers dispensing this specific injectable combination, and quality/compliance departments managing sterile drug products.
A lack of sterility assurance in injectable products represents a significant safety risk that typically triggers rigorous regulatory scrutiny of manufacturing or compounding processes. For regulatory professionals, this underscores the importance of aseptic processing controls and environmental monitoring, as failures in these areas lead to Class II enforcement actions and potential disruption of product availability.
QA and facility management should verify all sterile fill records for current inventory and review environmental monitoring data to ensure sterility assurance. Procurement teams should identify and isolate affected 2mL Tirzepatide/Niacinamide vials to prevent distribution during the ongoing recall process.
Class II. Reason: Lack of assurance of sterility.. Product: Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.. Firm: Houston Rx LLC (Houston TX United States). Status: Ongoing.
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