Drug recall
Indigo Carmine Injection, Indigotindisulfonate Sodium Injection USP, 0.8% Solution; 5 mL ampoules, 10 per…
FDA recall event 27427 · Class III · Akorn Inc.
Key facts
| Event ID | 27427 |
|---|---|
| Recall numbers | D-052-4 |
| Recalling firm | Akorn Inc. |
| Product type | Drugs |
| Products | Indigo Carmine Injection, Indigotindisulfonate Sodium Injection USP, 0.8% Solution; 5 mL ampoules, 10 per carton; Rx only, For Intravenous or Intramuscular use, Taylor Pharmaceuticals, Decatur, IL… |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The lot was manufactured from active (drug) pharmaceutical ingredient which failed to meet assay specifications |
| Initiation date | Sep 29, 2003 |
| City | Buffalo Grove |
| Country | United States |
| FEI number | 3003102962 |
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