FDA recall D-0341-2018
PD-Rx Pharmaceuticals, Inc. · Class II · drug
Product
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60
Reason for recall
CGMP deviations.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2018-01-25
- Report date
- 2018-02-07
- Termination date
- 2020-05-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Oklahoma City, OK, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0341-2018