Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 1…
Official notice from a government agency or its published feed.
Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
Reason: Failed Stability Specifications
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide in the USA.
Reason: Failed Stability Specifications
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide in the USA.
Hazard: Failed Stability Specifications
View the FDA enforcement report ↗ ← All reports