September 04, 2019
Aurobindo Pharma USA Inc. is recalling 2352 bottles of 40-mg simvastatin tablets because the product label contains incorrect lot information, according to the September 4, 2019, US Food and Drug Administration (FDA) Enforcement Report.
“Some bottles [are] labeled with lot number 05318054B instead of 05318034B,” the FDA explained.
The recall affects 1000-count bottles of simvastatin tablets, 40 mg (NDC 65862-053-99), labeled from lot 05318054B (Exp. 3/21). The bottles were distributed throughout the United States by three major distributors that may have further distributed the products.
Aurobindo Pharma USA voluntarily initiated the recall July 29, 2019. On August 26, 2019, the FDA designated the recall Class III. Under the recall classification, use of the recalled tablets is not likely to cause harm.
Simvastatin is a prescription medication used to treat patients with high cholesterol and triglyceride levels.