Drug recall
Cyclosporine 1%, 10 ml; store at room temperature
FDA recall event 73116 · Class II · Abbott's Compounding Pharmacy, Inc.
Key facts
| Event ID | 73116 |
|---|---|
| Recall numbers | V-483-2016, V-484-2016, V-485-2016 |
| Recalling firm | Abbott's Compounding Pharmacy, Inc. |
| Product type | Veterinary |
| Products | Cyclosporine 1%, 10 ml; store at room temperature, Cyclosporine 2%, 15 ml; store at room temperature, prednisolone acetate, 25 mg/ml, 40 ml unit size; store at room temperature |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. |
| Initiation date | Jan 15, 2016 |
| Report date | Aug 24, 2016 |
| Termination date | Apr 6, 2017 |
| City | Berkeley |
| State | CA |
| Country | United States |
| FEI number | 3005529620 |
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 · Source date: