FDA recall D-0558-2023

PD-Rx Pharmaceuticals, Inc. · Class II · drug

Product

Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)

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-0558-2023