Drug recall
Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL-Sterile, For the Eye Only, Rx only, Manufactured by…
FDA recall event 61101 · Class III · Sun Pharmaceutical Industries Ltd.
Key facts
| Event ID | 61101 |
|---|---|
| Recall numbers | D-1251-2012 |
| Recalling firm | Sun Pharmaceutical Industries Ltd. |
| Product type | Drugs |
| Products | Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL-Sterile, For the Eye Only, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Gujarat, India NDC 47335-938-90 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: The total impurities results were out of specification (OOS) during the analysis of 18 month controlled stability sample. |
| Initiation date | Feb 2, 2012 |
| Termination date | Aug 29, 2013 |
| City | Halol |
| Country | India |
| FEI number | 3002809586 |
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