Drug recall
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA…
FDA recall event 76432 · Class II · Teva Pharmaceuticals USA
Key facts
| Event ID | 76432 |
|---|---|
| Recall numbers | D-0517-2017 |
| Recalling firm | Teva Pharmaceuticals USA |
| Product type | Drugs |
| Products | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Initiation date | Feb 7, 2017 |
| Report date | Mar 22, 2017 |
| Termination date | Feb 16, 2018 |
| City | North Wales |
| State | PA |
| Country | United States |
| FEI number | 3003092769 |
At a glance
- 1–9 Products in this recall
- 1–9 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: