Drug recall
Pulmolite, Kit for the Preparation of Technetium Tc 99m Albumin Aggregated for Injection, 30 vial kit, Rx…
FDA recall event 58001 · Class III · Pharmalucence, Inc.
Key facts
| Event ID | 58001 |
|---|---|
| Recall numbers | D-452-2011 |
| Recalling firm | Pharmalucence, Inc. |
| Product type | Drugs |
| Products | Pulmolite, Kit for the Preparation of Technetium Tc 99m Albumin Aggregated for Injection, 30 vial kit, Rx only, Manufactured by: Pharmalucence, Inc., 10 Deangelo Dr., Bedford, MA USA 01730 NDC… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product Lacks Stability: Stability test data for particle size at 12-months found one particle >150um does not meet specfication |
| Initiation date | Feb 24, 2011 |
| Termination date | Sep 14, 2011 |
| City | Bedford |
| State | MA |
| Country | United States |
| FEI number | 1219718 |
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