Class II recall: Safecor Health, LLC: Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI,

Safecor Health, LLC has issued a Class II recall of Fluphenazine HCl Elixir, USP, 5 mg per 1 mL (10 mL delivery, NDC 00121-0653-04), citing failure to meet stability specifications. The product is an oral elixir containing 14% alcohol by volume, packaged by Safecor Health in Woburn, MA.

Most relevant for: Patients prescribed oral fluphenazine elixir for antipsychotic therapy, and pharmacies or facilities dispensing this specific lot.

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