Drug recall
Sufenta Injection, (Sufentanil Citrate), 50 mcg/mL (Sufentanil base),1 mL and 5 mL ampules, 10 ampules per…
FDA recall event 27310 · Class II · Akorn, Inc.
Key facts
| Event ID | 27310 |
|---|---|
| Recall numbers | D-030-4 |
| Recalling firm | Akorn, Inc. |
| Product type | Drugs |
| Products | Sufenta Injection, (Sufentanil Citrate), 50 mcg/mL (Sufentanil base),1 mL and 5 mL ampules, 10 ampules per carton; Rx Only, Taylor Pharmaceuticals, Decatur, IL 62522, NDC 11098-050-01 (1mL) and… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Unapproved New Drug; These lots were manufactured with an active ingredient produced according to a drug master file method not cited in the approved New Drug Application. |
| Initiation date | Sep 18, 2003 |
| City | Decatur |
| Country | United States |
| FEI number | 1419498 |
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