Class II · Moderate risk Ongoing
Fluphenazine Hydrochloride Tablets 2.5mg
Reason CGMP Deviations
Fluphenazine Decanoate Injection USP 125mg/5mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Discoloration; Hazy solution found in one vial instead of a clear solution.
What was recalled
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
- Recalling firm
- AuroMedics Pharma LLC
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0609-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Fluphenazine recalls
See all
Class II · Moderate risk Ongoing
Fluphenazine Hydrochloride Tablets
Reason CGMP Deviations
Class III · Low risk Terminated
Fluphenazine Decanoate Injection
Reason Subpotent Drug
Class II · Moderate risk Terminated
Fluphenazine HCl active pharmaceutical ingredient packaged in…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Fluphenazine Decanoate active pharmaceutical ingredient packaged…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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