Fluphenazine Decanoate Injection USP 125mg/5mL — Class II drug recall D-0609-2020
Terminated recall by AuroMedics Pharma LLC, reported 2019-12-11, distributed nationwide. Discoloration; Hazy solution found in one vial instead of a clear solution.
| Recall number | D-0609-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2019-11-12 |
| Classified | 2019-12-09 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2021-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 59,500 vials |
| Lot numbers | CFD190004 |
| Expiration dates | 2020-08-20 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0609-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.