Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot CFD190004, exp. date August 2020
Why it was recalled
Discoloration; Hazy solution found in one vial instead of a clear solution.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 59,500 vials
- Distribution pattern
- Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
Timeline
- Recall initiated
- 2019-11-12
- FDA classified
- 2019-12-09
- Posted by FDA
- 2019-12-11
- Terminated
- 2021-01-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0609-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.