Houston Rx LLC — Class II: Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 154
Houston Rx LLC has initiated a Class II recall for Sermorelin 1 mg/mL sterile injectable solution due to a lack of process control. The recall affects 10 mL vials and is currently classified as ongoing by the FDA.
This recall affects Houston Rx LLC, healthcare providers dispensing this specific injectable solution, and internal departments responsible for sterile manufacturing and quality control.
A 'lack of process control' designation in sterile injectables typically suggests a failure to adhere to validated manufacturing protocols or environmental monitoring standards. This indicates a potential risk to product sterility or consistency, necessitating a review of CGMP compliance and sterile processing validations to prevent recurrence.
QA and manufacturing teams should review current process control documentation and validation data for sterile fill operations. Firms should ensure that all critical process parameters are defined and monitored to prevent deviations that could compromise product sterility or potency.
Class II. Reason: Lack of process control. Product: Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.. Firm: Houston Rx LLC (Houston TX United States). Status: Ongoing.
Open in openFDA / FDA.gov