Statin Recalled

Direct Rx is recalling 4 strengths of simvastatin tablets due to deviations from Current Good Manufacturing Practices, according to the April 5, 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 Direct Rx, Dawsonville, Georgia:

• 5-mg simvastatin tablets in 90-count bottles (NDC 61919-0710-90) from lots 03JA2209 (Exp 6/30/23), 28FE2225 (Exp 6/30/23), 28AP2211 (Exp 6/30/23), and 07AP2203 (Exp 6/30/23);
• 10-mg simvastatin tablets in 30-count bottles (NDC 61919-0688-30) from lot 05AU2206 (Exp 10/31/23);
• 10-mg simvastatin tablets in 90-count bottles (NDC61919-0688-90) from lots 30MA2213 (Exp 6/30/23), 10DE2124 (Exp 3/31/23), 15MA2224 (Exp 5/32/23), and 27JA2229 (Exp 3/31/23);
• 20-mg simvastatin tablets in 30-count bottles (NDC 61919-0446-30) from lot 09JA2312 (Exp 2/28/25);
• 20-mg simvastatin tablets in 90-count bottles (NDC 61919-0446-90) from lots 22OC2111 (Exp 1/31/23), 13OC2120 (Exp 3/31/23), 16JY2104 (Exp 12/31/23), 09AU2125 (Exp 1/31/24), 28JY2125 (Exp 1/31/24), 23SE2115 (Exp 3/31/24), 23SE2115 (Exp 3/31/24), 07JA2211 (Exp 5/31/24), 27JA2214 (Exp 5/31/24), 15AP2224 (Exp 6/30/24), 24MA2221 (Exp 6/30/24), and 16AU2214 (Exp 6/30/24); and
• 40-mg simvastatin tablets in 90-count bottles (NDC 61919-0431-90) from lots 28AP2212 (Exp 7/31/24), 24MA2230 (Exp 7/31/24), 11JA2203 (Exp 3/31/23), 02FE2217 (Exp 2/28/23), 10DE2126 (Exp 2/28/23), 25MA2201 (Exp 5/31/23), and 28FE2230 (Exp 5/31/23).

Direct Rx voluntarily initiated the recall March 13, 2023. On March 24, 2023, the FDA designated the recall Class II, communicating use of the 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.