Micro Labs announced a voluntary recall of 54,096 bottles of Simvastatin Tablets due to failed impurities/degradation specifications. The Class-III recall was initiated on December 4, 2014.

The affected products are as follows:

20mg tablets: 27,144 bottles(Lot #STCG005, Exp 1/2015; Lot #STCG011, Exp 3/2015; Lot #STCG012, Exp 2/2015)
40mg tablets: 13,488 bottles (Lot #STDG010, Exp 3/2015)
80mg tablets: 13,464 bottles (Lot #STEG004, Exp 2/2015; Lot #STEG006, Exp 3/2015)

Simvastatin is a HMG-CoA reductase inhibitor indicated as adjunct to diet when response to nondrug therapy is inadequate: primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Types lla and llb) to reduce elevated total-C, LDL-C, apo B and TG, and to increase HDL-C; hypertriglyceridemia (Type IV) or primary dysbetalipoproteinemia (Type III); adjunct to or when other lipid-lowering treatments for homozygous familial hypercholesterolemia (HoFH) are not available, to reduce total-C and LDL-C; in patients with coronary heart disease (CHD), diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease to reduce: risk of total mortality by reducing CHD death, risk of non-fatal MI and stroke, risk for undergoing myocardial revascularization procedures; adjunct to diet to reduce total-C, LDL-C, and apo B in patients 10–17 years of age (≥1yr post-menarche) with heterozygous familial hypercholesterolemia if LDL-C remains ≥190mg/dL, or if LDL-C remains ≥160mg/dL with either family history of premature cardiovascular disease (CVD) or if patient has at least two other CVD risk factors.

For more information visit MicroLabs.com.

Over 50,000 Bottles of Cholesterol Drug Recalled

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