Drug recall
Sertraline Hydrochloride Oral Concentrate, 20 mg/mL, 60 mL bottle, RX only, NDC 0054-0082-46, Boehringer…
FDA recall event 46966 · Class II · Boehringer Ingelheim Roxane Incorporated
Key facts
| Event ID | 46966 |
|---|---|
| Recall numbers | D-196-2008 |
| Recalling firm | Boehringer Ingelheim Roxane Incorporated |
| Product type | Drugs |
| Products | Sertraline Hydrochloride Oral Concentrate, 20 mg/mL, 60 mL bottle, RX only, NDC 0054-0082-46, Boehringer Ingelheim, Roxane Laboratories, Inc., Columbus, OH. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product does not meet degradation specifications over shelf life. |
| Initiation date | Mar 3, 2008 |
| Termination date | Sep 19, 2012 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 1510690 |
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