Drug recall
Fluconazole Tablets, 100 mg, 30-count bottle, NDC 0172-5411-46, Rx only, Manufactured in India by Cipla Ltd…
FDA recall event 58965 · Class II · Teva Pharmaceuticals USA, Inc.
Key facts
| Event ID | 58965 |
|---|---|
| Recall numbers | D-898-2011 |
| Recalling firm | Teva Pharmaceuticals USA, Inc. |
| Product type | Drugs |
| Products | Fluconazole Tablets, 100 mg, 30-count bottle, NDC 0172-5411-46, Rx only, Manufactured in India by Cipla Ltd. Kurkumbh, India, Manufactured for, Teva Pharmaceuticals USA Sellersville, PA 18960, |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Adulterated Presence of Foreign Tablets; There is the potential for the presence of 200 mg tablets comingled in bottles of product labeled 100 mg |
| Initiation date | Jun 3, 2011 |
| Termination date | Jun 1, 2012 |
| City | Sellersville |
| State | PA |
| Country | United States |
| FEI number | 2517175 |
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