FDA recall D-1863-2019
West-Ward Columbus Inc · Class II · drug
Product
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59
Reason for recall
Failed Impurities/Degradation Specificattion
Distribution
Nationwide USA and Puerto Rico
Key facts
- Status
- Terminated
- Initiation date
- 2019-09-09
- Report date
- 2019-09-25
- Termination date
- 2022-06-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Columbus, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1863-2019