Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-0609-2020

November 12, 2019

Class II

Product summary

Firm
AuroMedics Pharma LLC
Event
Event 84244
Status
Terminated
Classification
Class II
Quantity
59,500 vials
Official record key
drug-enforcement:D-0609-2020

Official wording

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

Code information: Lot CFD190004, exp. date August 2020

Distribution pattern: Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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