Drug recall
EDTA, Disodium Salt Dihydrate, USP (Ethylenediamine Tetraacetic Acid, Disodium Salt Dihydrate), bulk drug for…
FDA recall event 37967 · Class III · ThermoFisher Scientific Co., LLC
Key facts
| Event ID | 37967 |
|---|---|
| Recall numbers | D-831-2007 |
| Recalling firm | ThermoFisher Scientific Co., LLC |
| Product type | Drugs |
| Products | EDTA, Disodium Salt Dihydrate, USP (Ethylenediamine Tetraacetic Acid, Disodium Salt Dihydrate), bulk drug for laboratory and commercial manufacturing use packaged in 500 g plastic bottles and 12 Kg… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product exceeds USP specification for nitrilotriacetic acid impurity. |
| Initiation date | May 1, 2007 |
| Termination date | Apr 16, 2008 |
| City | Fair Lawn |
| State | NJ |
| Country | United States |
| FEI number | 2214740 |
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