Safecor Health, LLC — Class II: Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14
Safecor Health, LLC has initiated a Class II recall for Fluphenazine HCl Elixir (5 mg per 1 mL, 10 mL delivery) due to failed stability specifications. The recall is currently listed as ongoing for the affected NDC: 00121-0653-04.
This recall affects Safecor Health, LLC, healthcare facilities, and pharmacies utilizing this specific repackaged fluphenazine elixir, as well as quality control departments responsible for stability monitoring.
A Class II recall for failed stability suggests that the product may not maintain its potency, purity, or identity throughout its labeled shelf life. For regulatory and quality professionals, this indicates a potential breakdown in the stability testing program or a formulation issue that could impact therapeutic efficacy, though the risk of serious adverse health consequences is generally considered remote in Class II scenarios.
Quality and supply chain teams should immediately identify and sequester the specified NDC (00121-0653-04). QA should review stability data for similar liquid formulations to ensure current monitoring programs remain robust enough to detect out-of-specification trends before distribution.
Class II. Reason: Failed Stability Specifications. Product: Fluphenazine HCl Elixir, USP, 5 mg per 1 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: 00121-0653-04. Firm: Safecor Health, LLC (Woburn MA United States). Status: Ongoing.
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