FDA recall D-1441-2016
West-Ward Columbus Inc · Class III · drug
Product
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
Reason for recall
Failed Impurities/Degradation Specification; 9 month stability
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2016-05-19
- Report date
- 2016-07-20
- Termination date
- 2017-02-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Columbus, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1441-2016