Drug recall
Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical…
FDA recall event 70339 · Class II · Sun Pharma Global Fze
Key facts
| Event ID | 70339 |
|---|---|
| Recall numbers | D-0386-2015 |
| Recalling firm | Sun Pharma Global Fze |
| Product type | Drugs |
| Products | Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: 6 month time point. |
| Initiation date | Jan 21, 2015 |
| Report date | Feb 18, 2015 |
| Termination date | Oct 23, 2015 |
| City | Sharm |
| Country | United Arab Emirates |
| FEI number | 3008255475 |
At a glance
- 1–9 Products in this recall
- None 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: