Safety alertSource: FDA Drug Enforcement Reports
Class II recall: Safecor Health, LLC: Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI,
Safecor Health, LLC has issued a Class II recall of Fluphenazine HCl Elixir, USP (15 mg per 3 mL, delivering 10 mL oral elixir, NDC 00121-0653-04), packaged in Woburn, MA. The recall was initiated because the product failed stability specifications.
Most relevant for: Patients prescribed oral fluphenazine elixir for management of psychotic disorders.
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