FDAFDA · Food and drugs·Recall number D-0609-2020
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
Published December 11, 2019 · Recall initiated: November 12, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Discoloration; Hazy solution found in one vial instead of a clear solution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
- Lot
- Lot CFD190004, exp. date August 2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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