Drug 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.
Lots and codes
Lot CFD190004, exp. date August 2020
Recall details
- Recalling firm
- AuroMedics Pharma LLC, East Windsor, NJ
- Quantity
- 59,500 vials
- Distribution
- Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 12, 2019
- Terminated
- January 21, 2021