FDA-Drug2023-05-10Class II

Simvastatin USP 40 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 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)

PD-Rx Pharmaceuticals, Inc.
Hazard

CGMP deviations.

Sold states
Nationwide in the US.
Affected count
393 bottles
Manufactured in
727 N Ann Arbor Ave, Oklahoma City, OK, United States
Products
Simvastatin USP 40 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 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0561-2023

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