Drug recall
DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by…
FDA recall event 78947 · Class II · Sun Pharmaceutical Industries, Inc.
Key facts
| Event ID | 78947 |
|---|---|
| Recall numbers | D-0229-2018 |
| Recalling firm | Sun Pharmaceutical Industries, Inc. |
| Product type | Drugs |
| Products | DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack Of Assurance Of Sterility |
| Initiation date | Jan 16, 2018 |
| Report date | Jan 31, 2018 |
| Termination date | Sep 14, 2018 |
| City | Cranbury |
| State | NJ |
| Country | United States |
| FEI number | 3005551493 |
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: