FDA recall D-0609-2020

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-11-12

Report date

2019-12-11

Termination date

2021-01-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0609-2020