Safecor Health, LLC — Class II: Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 1
Safecor Health, LLC has initiated a Class II recall for Fluphenazine HCl Elixir, USP (15 mg per 3 mL, 10 mL delivery) due to failed stability specifications. The recall, which is currently ongoing, affects products packaged at the Woburn, MA facility.
This recall affects Safecor Health, LLC, healthcare providers dispensing this specific NDC, and pharmacy departments utilizing repackaged Fluphenazine HCl oral elixirs.
Stability failures suggest that the product may not maintain its potency, purity, or physical characteristics throughout its labeled shelf life. For an antipsychotic medication like Fluphenazine, failure to meet specifications could potentially impact therapeutic consistency. The Class II designation implies that exposure to the product may cause temporary or medically reversible adverse health consequences, though the probability of serious consequences is remote.
Quality units should audit stability testing data for liquid formulations to ensure specifications are met throughout the shelf life. Supply chain teams should identify and sequester any inventory matching NDC 00121-0653-04. Regulatory and QA teams should review internal change controls or environmental monitoring if the stability failure is linked to packaging or storage conditions.
Class II. Reason: Failed Stability Specifications. Product: Fluphenazine HCl Elixir, USP, 15 mg per 3 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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