Safecor Health, LLC — Class II: Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 1
Safecor Health, LLC has initiated a Class II recall for Fluphenazine HCl Elixir, USP (10 mg per 2 mL) due to failure to meet stability specifications. The recall affects the 10 mL delivery volume packaged by the firm's Woburn, MA facility.
This recall affects Safecor Health, LLC, pharmacy distributors, and healthcare providers utilizing unit-dose fluphenazine HCl elixir (NDC 00121-0653-04). Clinical and pharmacy staff responsible for medication dispensing are also impacted.
A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The failure to meet stability specifications suggests potential issues with active ingredient potency or degradant levels over time, which may necessitate an investigation into the packaging process or the bulk product's stability profile under specific storage conditions.
Review current inventory for NDC 00121-0653-04 and segregate affected units. Quality teams should evaluate stability testing protocols and storage conditions for fluphenazine elixirs to ensure ongoing compliance with USP specifications throughout the product shelf life.
Class II. Reason: Failed Stability Specifications. Product: Fluphenazine HCl Elixir, USP, 10 mg per 2 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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