Safecor Health, LLC — Class II: Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 1
Safecor Health, LLC has initiated a Class II recall for Fluphenazine HCl Elixir, USP (5 mg per 10 mL) due to failed stability specifications. The recall is currently classified as ongoing and affects product packaged by the firm's Woburn, MA facility.
This affects Safecor Health, LLC, healthcare providers, and pharmacy distributors utilizing this specific NDC (00121-0654-16) of Fluphenazine HCl Elixir. Quality and compliance personnel at repackaging facilities are also affected.
A Class II recall due to stability failure suggests that the product may not maintain its labeled potency or physical characteristics throughout its shelf life. For regulatory professionals, this underscores the importance of robust stability programs for repackaged liquid oral dosage forms, particularly those containing alcohol, which may be susceptible to evaporation or degradation. Failure to meet USP specifications indicates a potential lapse in manufacturing or environmental controls.
Quality units should verify if affected lots are in inventory and initiate quarantine procedures. Regulatory and QA teams should review stability testing protocols and retain sample data to ensure ongoing compliance with USP specifications for elixir formulations.
Class II. Reason: Failed Stability Specifications. Product: Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16. Firm: Safecor Health, LLC (Woburn MA United States). Status: Ongoing.
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