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FDARecalled Sep 23, 2026 · #D-0845-2026

Fluphenazine HCl Elixir, USP, 15 mg per 3 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

Hazard

Class II — temporary health risk

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Description

Failed Stability Specifications Classification: Class II Distribution: Nationwide in the USA.

Product details

Product
Fluphenazine HCl Elixir, USP, 15 mg per 3 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
Type
Drugs
Manufacturer
Safecor Health, LLC
Model numbers
26080483, 25310327, 25330414, 25430340
UPCs
—