Class II recall: Safecor Health, LLC: Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI,
Safecor Health, LLC has issued a Class II recall for Fluphenazine HCl Elixir, USP, 5 mg per 10 mL (NDC: 00121-0654-16), an oral elixir containing 14% alcohol by volume. The FDA recall notice states the product failed stability specifications. No further details on the specific failure or clinical consequences were provided in the source text.
Most relevant for: Patients prescribed fluphenazine oral elixir for management of psychotic disorders.
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Informational only. Not medical advice. Not a substitute for clinical judgment. Always consult current guidelines and your own clinical judgment.
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