Drug recall
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur…
FDA recall event 88885 · Class III · Lupin Pharmaceuticals Inc.
Key facts
| Event ID | 88885 |
|---|---|
| Recall numbers | D-0091-2022 |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. |
| Initiation date | Oct 20, 2021 |
| Report date | Nov 3, 2021 |
| Termination date | Aug 23, 2022 |
| City | Baltimore |
| State | MD |
| Country | United States |
| FEI number | 3004097115 |
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: