FDA recall D-0557-2023
PD-Rx Pharmaceuticals, Inc. · Class II · drug
Product
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
Reason for recall
CGMP deviations.
Distribution
Nationwide in the US.
Key facts
- Status
- Terminated
- Initiation date
- 2023-04-06
- Report date
- 2023-05-10
- Termination date
- 2024-04-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Oklahoma City, OK, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0557-2023