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.