Drug recall
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH…
FDA recall event 66528 · Class II · Actavis Elizabeth LLC
Key facts
| Event ID | 66528 |
|---|---|
| Recall numbers | D-018-2014 |
| Recalling firm | Actavis Elizabeth LLC |
| Product type | Drugs |
| Products | Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets |
| Initiation date | Oct 9, 2013 |
| Report date | Dec 4, 2013 |
| Termination date | Nov 3, 2014 |
| City | Elizabeth |
| State | NJ |
| Country | United States |
| FEI number | 2211563 |
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: