Drug recall
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens…
FDA recall event 80387 · Class II · Sanofi-Aventis U.S. LLC
Key facts
| Event ID | 80387 |
|---|---|
| Recall numbers | D-0925-2018 |
| Recalling firm | Sanofi-Aventis U.S. LLC |
| Product type | Drugs |
| Products | Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature. |
| Initiation date | Jul 5, 2018 |
| Report date | Jul 18, 2018 |
| City | Bridgewater |
| State | NJ |
| Country | United States |
| FEI number | 2222017 |
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 · Source date: