Drug recall
Metronidazole Tablets USP, 500 mg, 500-count bottle, Rx only, Mfg. by PLIVA Krakow Pharmaceutical Company…
FDA recall event 59583 · Class II · Teva Pharmaceuticals USA, Inc.
Key facts
| Event ID | 59583 |
|---|---|
| Recall numbers | D-871-2011 |
| Recalling firm | Teva Pharmaceuticals USA, Inc. |
| Product type | Drugs |
| Products | Metronidazole Tablets USP, 500 mg, 500-count bottle, Rx only, Mfg. by PLIVA Krakow Pharmaceutical Company S.A., Krakow, Poland for PLIVA, Inc., Pomona, NY 10970; Dist. by Barr Laboratories, Inc… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Foreign Substance(s): Recall is being conducted due to the potential that some tablets may contain foreign material. |
| Initiation date | Aug 4, 2011 |
| Termination date | Sep 25, 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