D-0609-2020 Class II Terminated
FDA drug recall D-0609-2020 was initiated by AuroMedics Pharma LLC on Nov 12, 2019 and is designated Class II. Reason for recall: Discoloration; Hazy solution found in one vial instead of a clear solution. The recall status is terminated (terminated Jan 21, 2021). Affected quantity: 59,500 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 11, 2019
- Initiation Date
- Nov 12, 2019
- Termination Date
- Jan 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59,500 vials
Product Description
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 Pattern
Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
Code Information
Lot CFD190004, exp. date August 2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0609-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026