Safety alertSource: FDA Drug Enforcement Reports

Class II recall: Safecor Health, LLC: Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI,

Safecor Health, LLC has issued a Class II recall of Fluphenazine HCl Elixir, USP (10 mg per 2 mL, 10 mL delivery, NDC 00121-0653-04), an oral elixir containing 14% alcohol by volume. The recall was initiated because the product failed stability specifications, according to the recall notice.

Most relevant for: Patients currently dispensed this specific lot of oral fluphenazine elixir for psychiatric treatment.

Read the original at FDA Drug Enforcement Reports

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