Drug recall
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc…
FDA recall event 79278 · Class III · Akorn, Inc.
Key facts
| Event ID | 79278 |
|---|---|
| Recall numbers | D-0577-2018 |
| Recalling firm | Akorn, Inc. |
| Product type | Drugs |
| Products | Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Stability Specification: OOS low viscosity results discovered during retain testing. |
| Initiation date | Feb 21, 2018 |
| Report date | Mar 14, 2018 |
| Termination date | Aug 31, 2020 |
| City | Lake Forest |
| State | IL |
| 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 · Source date: