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FDANovember 12, 2019drug

Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Discoloration; Hazy solution found in one vial instead of a clear solution.

What to do

FDA enforcement status: Terminated

Brands named

auromedics pharmaauromedics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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