Drug recall
OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane…
FDA recall event 68879 · Class III · Boehringer Ingelheim Roxane Inc
Key facts
| Event ID | 68879 |
|---|---|
| Recall numbers | D-1486-2014 |
| Recalling firm | Boehringer Ingelheim Roxane Inc |
| Product type | Drugs |
| Products | OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Stability Specifications: Out of specification result for preservative sodium benzoate. |
| Initiation date | Jul 28, 2014 |
| Report date | Aug 6, 2014 |
| Termination date | May 29, 2015 |
| 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 · Source date: