Class II recall: Safecor Health, LLC: Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI,

Safecor Health, LLC issued a Class II recall for Fluphenazine HCl Elixir, USP, 20 mg per 4 mL (delivers 10 mL), NDC 00121-0653-04, packaged by Safecor Health in Woburn, MA. The recall was initiated because the product failed stability specifications, according to the recall notice. The product is an oral elixir containing 14% alcohol by volume, labeled for oral use only.

Most relevant for: Patients prescribed fluphenazine HCl elixir for psychiatric conditions and the clinicians and pharmacies dispensing this specific lot.

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