Cholesterol Drug Recalled

Dr Reddy’s Laboratories Inc is recalling numerous lots of ezetimibe and simvastatin tablets because they were manufactured using an excipient found to be out of specification for conductivity, according to the November 10, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured by Dr Reddy's Laboratories Shreveport, LA, and distributed throughout the United States by Dr Reddy's Laboratories Inc, Princeton, NJ:

• Dr Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, in 90-count bottles (NDC 43598-742-90), from lot L100256 (Exp. 1/23);
• Dr Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, in 1000-count bottles (NDC 43598-742-10), from lot L100257 (Exp. 1/23);
• Dr Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, in 30-count bottles (NDC 43598-744-30), from lots L100298 and L100304 (Exp. 1/23);
• Dr Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, in 90-count bottles (NDC 43598-744-90), from lot L100235 (Exp. 1/23);
• Dr Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, in 30-count bottles (NDC 43598-743-30), from lot L100158 (Exp. 12/22);
• Dr Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, in 90-count bottles (NDC 43598-743-90), from lot L100159 (Exp. 12/22);
• Dr Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, in 500-count bottles (NDC 43598-743-05), from lot L100208 (Exp. 1/23) (In addition to the out-of-specification excipient used in manufacturing, bottles from this lot also were found to contain 10 mg/10 mg tablets, according to the FDA);
• Dr Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, in 30-count bottles (NDC 43598-745-30), from lot L100160 (Exp. 1/23);
• Dr Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, in 90-count bottles (NDC 43598-745-90), from lot L100249 (Exp. 1/23); and
• Dr Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, in 500-count bottles (NDC 43598-745-05), from lot L100250 (Exp. 1/23).

Dr Reddy’s Laboratories voluntarily initiated the recalls October 5, 2021. On October 29, 2021, the FDA designated them Class II, communicating that use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Ezetimibe and simvastatin tablets are available with a prescription to lower high cholesterol and triglyceride levels.