Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Micro Labs Usa, Inc S

NDC code

42571-0020-10

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0407-2015

Other Simvastatin recalls

See all

Class III · Low risk Ongoing May 19, 2025

Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No…

Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time…

Glenmark Pharmaceuticals Inc., USA NDC 68462-323-90 D-0462-2025

Class II · Moderate risk Terminated Apr 6, 2023

Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0726-30 D-0561-2023

Class II · Moderate risk Terminated Apr 6, 2023

Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-008-30 D-0560-2023

Class II · Moderate risk Terminated Apr 6, 2023

Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0727-30 D-0558-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c)…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-9868-9 D-0525-2023