FDA Drug recall D-0609-2020
Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma,…
- FDA Drug
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma,… by Auromedics Pharma, citing discoloration; Hazy solution found in one vial instead of a clear solution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0609-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-12 |
| Published | 2019-12-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | US |
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
Discoloration; Hazy solution found in one vial instead of a clear solution.
Identifiers
| code_info | Lot CFD190004, exp. date August 2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0609-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.