Drug recall
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of…
FDA recall event 90618 · Class II · Zydus Pharmaceuticals (USA) Inc
Key facts
| Event ID | 90618 |
|---|---|
| Recall numbers | D-1351-2022 |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Product type | Drugs |
| Products | Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Initiation date | Jul 15, 2022 |
| Report date | Aug 24, 2022 |
| Termination date | Jun 18, 2024 |
| City | Pennington |
| State | NJ |
| Country | United States |
| FEI number | 3008444937 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: