Drug recall
Twinject ¿ 0.3 mg Auto-Injector (epinephrine injection, USP 1:1000), Rx only, Manufactured for and Distributed…
FDA recall event 53464 · Class III · Sciele Pharma, Inc.
Key facts
| Event ID | 53464 |
|---|---|
| Recall numbers | D-031-2010 |
| Recalling firm | Sciele Pharma, Inc. |
| Product type | Drugs |
| Products | Twinject ¿ 0.3 mg Auto-Injector (epinephrine injection, USP 1:1000), Rx only, Manufactured for and Distributed by: Sciele Pharma, Inc., Atlanta, GA; NDC 59630-802-01. Note that this lot of Twinject is… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defective Delivery System; High Force-To-Fire values for the 12 month pull performance testing of Twinject 2008 annual stability units |
| Initiation date | Sep 23, 2009 |
| Termination date | Apr 1, 2010 |
| City | Atlanta |
| State | GA |
| Country | United States |
| FEI number | 3004530896 |
At a glance
- 1–9 Products in this recall
- 10–99 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