Safecor Health, LLC — Class II: Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 1
Safecor Health, LLC has initiated an ongoing Class II recall for Fluphenazine HCl Elixir, USP (20 mg per 4 mL) due to failed stability specifications. The recall affects product packaged at the Woburn, MA facility under NDC 00121-0653-04.
This recall affects Safecor Health, LLC, pharmacy distributors, and healthcare facilities utilizing these specific repackaged unit-dose elixirs, as well as QA and supply chain personnel responsible for product integrity.
A Class II recall due to stability failure suggests that the product may not maintain its strength, quality, or purity through the expiration date. For regulatory and quality teams, this indicates a potential issue in the repackaging process or the primary container closure system's ability to maintain the product's USP specifications over time.
Quality units should immediately verify inventory for the affected NDC, segregate identified stock, and review internal stability data for similar liquid formulations to ensure current specifications are being met throughout the product lifecycle.
Class II. Reason: Failed Stability Specifications. Product: Fluphenazine HCl Elixir, USP, 20 mg per 4 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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