FDA-Drug2019-12-11Class II
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
AuroMedics Pharma LLC
Hazard
Discoloration; Hazy solution found in one vial instead of a clear solution.
Sold states
Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
Affected count
59,500 vials
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0609-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief