Statin Tablets Recalled

PD-Rx Pharmaceuticals Inc is recalling 950 bottles of simvastatin tablets because of deviations from Current Good Manufacturing Practices, according to the May 10, 2023, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects the following products, which were packaged and distributed throughout the United States by PD-Rx Pharmaceuticals Inc, Oklahoma City, Oklahoma:

• 10-mg simvastatin tablets in 30-count bottles (NDC 43063-0727-30) from lot K22E32 (Exp 10/31/23);
• 10-mg simvastatin tablets in 90-count bottles (NDC 43063-0727-90) from lots H22C33 (Exp 9/30/23); and H22C81, J22C83, and K22E36 (Exp 10/31/23);
• 20-mg simvastatin tablets in 30-count bottles (NDC 43063-008-30) from lots G22B32, D22B92, and D22F82 (Exp 6/30/23); G22F41, J22F25, and L22C14 (Exp 1/31/24); D22B92 and D22F82 (Exp 6/30/23); and B22A12 (Exp 3/31/23);
• 20-mg simvastatin tablets in 90-count bottles (NDC 43063-0008-90) from lots H22A32, I22E83, J22E94, and K22E34 (Exp 1/31/24); C22F31, D22G16, E22D75, F22E06 (Exp 6/30/23); and L21E09 and B22C61 (Exp 1/31/23);
• 40-mg simvastatin tablets in 30-count bottles (NDC 43063-0726-30) from lots A22A17 and D22C21 (Exp 7/31/23); K22D89, L22B26, and L22D14 (Exp 3/31/24); and L22D96 (Exp 4/30/24); and
• 40-mg simvastatin tablets in 90-count bottles (NDC 43063-0726-90) from lots L21E06 (Exp 5/31/23), B22C05, D22B91, and E22C82 (Exp 7/31/23); G22B03 G22B79, H22A30, and J22B81 (Exp 8/31/23); J22F27, K22B37, and K22B88 (Exp 10/31/23); L22D32 (Exp 3/31/24); and B23E07 (Exp 4/30/24).

PD-Rx Pharmaceuticals voluntarily initiated the recall on April 6, 2023. The FDA designated the recall Class II on May 1, 2023. The classification suggests use of the affected drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Simvastatin is a prescription medication used to treat high cholesterol and triglyceride levels and reduce the risk of heart attack, stroke, and related conditions.