Drug recall
Azithromycin Tablets, 250 mg, 6 x 1 blister packs, Rx only, Manufactured in Israel by Teva Pharmaceutical IND…
FDA recall event 57994 · Class II · Teva Pharmaceuticals USA, Inc.
Key facts
| Event ID | 57994 |
|---|---|
| Recall numbers | D-563-2011, D-564-2011 |
| Recalling firm | Teva Pharmaceuticals USA, Inc. |
| Product type | Drugs |
| Products | Azithromycin Tablets, 250 mg, 6 x 1 blister packs, Rx only, Manufactured in Israel by Teva Pharmaceutical IND Ltd, Jerusalem, 91010, Israel; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA…, Azithromycin Tablets, 500 mg, 30 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND Ltd, Jerusalem, 91010, Israel; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for… |
| Initiation date | Feb 23, 2011 |
| Termination date | Aug 16, 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