February 01, 2019
Dr. Reddy's Laboratories Inc. is recalling 118 bottles of ezetimibe and simvastatin tablets, 10 mg/80 mg, after black speckles on tablets were reported. The recall was included in the January 30, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 1000-count bottles (NDC 43598-586-10) from lots 43E021 and 43E023 (Exp. 1/20). The tablets were manufactured by Teva Pharmaceuticals Ind. Ltd. and distributed throughout the United States by Dr. Reddy's Laboratories.
Dr. Reddy's Laboratories voluntarily initiated the recall January 15, 2019. On January 22, 2019, the FDA designated it Class II. The classification suggests use of the product could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.
Ezetimibe and simvastatin tablets are available with a prescription to improve cholesterol levels.
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