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FDARecalled Sep 23, 2026 · #D-0842-2026

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

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, 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
Type
Drugs
Manufacturer
Safecor Health, LLC
Model numbers
25330169, 25340107, 25370044, 25391430, 25411035, 25461036, 25450206, 25521269, 26030426, 26071765, 26111371, 26121435, 26141209, 26151211, 26170561, 26171144, 26191168, 26210307, 26231182, 26241285
UPCs
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