Drug recall
AMIODARONE HCl Injection, 150mg/3mL (50mg/mL), 10 Single Use Vials, FOR IV USE ONLY, MUST BE DILUTED, Rx ONLY…
FDA recall event 47830 · Class III · Bedford Laboratories
Key facts
| Event ID | 47830 |
|---|---|
| Recall numbers | D-217-2008 |
| Recalling firm | Bedford Laboratories |
| Product type | Drugs |
| Products | AMIODARONE HCl Injection, 150mg/3mL (50mg/mL), 10 Single Use Vials, FOR IV USE ONLY, MUST BE DILUTED, Rx ONLY, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146. Manufactured for: Bedford… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter; vials contained crystalized active ingredient |
| Initiation date | Apr 21, 2008 |
| Termination date | Oct 22, 2009 |
| City | Bedford |
| State | OH |
| Country | United States |
| FEI number | 3003737603 |
At a glance
- 1–9 Products in this recall
- None 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