Drug recall
Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva…
FDA recall event 66899 · Class III · Teva Pharmaceuticals USA, Inc.
Key facts
| Event ID | 66899 |
|---|---|
| Recall numbers | D-747-2014 |
| Recalling firm | Teva Pharmaceuticals USA, Inc. |
| Product type | Drugs |
| Products | Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Stability Specifications: this product is below specification for preservative content. |
| Initiation date | Nov 14, 2013 |
| Report date | Jan 29, 2014 |
| Termination date | Aug 27, 2014 |
| 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 · Source date: