FDA recall D-0560-2023

Product

Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)

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-0560-2023