Class II
Terminated
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
This recall has been terminated (originally issued December 11, 2019).
- Company
- Auromedics Pharma Llc
- Recall Initiated
- November 12, 2019
- Posted
- December 11, 2019
- Recall Number
- D-0609-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 59,500 vials
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot CFD190004, exp. date August 2020
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