FDA Drug Class II — Moderate

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

Hazard

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

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Products

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
Brand
AuroMedics Pharma LLC
UPC
Lot CFD190004, exp. date August 2020

Units Affected

59,500 vials

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