Drug recall
Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech…
FDA recall event 76421 · Class III · Actavis Inc
Key facts
| Event ID | 76421 |
|---|---|
| Recall numbers | D-0514-2017 |
| Recalling firm | Actavis Inc |
| Product type | Drugs |
| Products | Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point. |
| Initiation date | Feb 7, 2017 |
| Report date | Mar 15, 2017 |
| Termination date | Jan 9, 2018 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3010259842 |
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: