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Medicine / D-0841-2026

U.S. Food and Drug AdministrationD-0841-2026

Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health,…

Class II Distributed nationwide or U.S.-wide Status: Ongoing

What was recalled

Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16

Recalling firm

Safecor Health, LLC

Reason for recall

Failed Stability Specifications

Where it went

Nationwide in the USA.

Shown as U.S. Food and Drug Administration published it (shortened where marked …). Recall Shelf does not change recall facts and is not affiliated with the agency.