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WebMD Health News Reviewed byLouise Chang, MD
Nov. 30, 2012 -- After recalling 41 lots of its generic Lipitor -- atorvastatin -- the FDA says Ranbaxy Inc. will stop making the drug "until it has thoroughly investigated" how glass particles got into the medication.
Although Ranbaxy supplied more than 40% of the generic cholesterol-lowering drug sold in the U.S., the FDA says it does not expect a shortage. Five other firms make generic Lipitor: Sandoz, Teva, Apotex, Mylan, and Dr. Reddy's.
The FDA says the tiny glass particles contaminating Ranbaxy's atorvastatin have only "a remote possibility" of causing harm. Ranbaxy says the particles, about the size of a grain of sand, might cause "physical irritation."
Ranbaxy makes atorvastatin, and puts it into pill form at its U.S. facilities. The active ingredient, however, comes from India. Ranbaxy's preliminary investigation suggests that this active ingredient was contaminated with the glass particles, according to FDA public information officer Sarah Clark-Lynn.
To date, there have been no reports of harm linked to Ranbaxy generic Lipitor.
It's not the first sign of trouble for Ranbaxy, the huge Indian pharmaceutical company owned by Japan's Daiichi Sankyo. Last January, the company signed an FDA-requested consent decree closing plants in India and the U.S. until it made "fundamental changes." None of those plants made the recently recalled generic Lipitor products.
The company admitted to several serious charges, including submitting false data to the FDA, failing to prevent contamination of sterile drugs, failing to prevent penicillin contamination of non-penicillin drugs, and inadequate testing of drugs to ensure they kept their potency until their expiration date.
The U.S. Justice Department said the action was "unprecedented in its scope."
Recalled Generic LipitorThe recalled atorvastatin comes as a white tablet packaged in plastic bottles. The 10-mg tablets bear the imprint "RX12," the 20-mg tablets bear the imprint ''RX828," and the 40-mg tablets bear the imprint "RX829." No 80-mg tablets are included in the recall.
Here's the list of the recalled atorvastatin products:
Product Lot Number Pack Size NDC # Expiry Date ATORVASTATIN Calcium Tablets 10mg x 90 2436144 90's Bottle 63304-827-90 31-Aug-14 ATORVASTATIN Calcium Tablets 10mg x 90 2436582 90's Bottle 63304-827-90 31-Aug-14 ATORVASTATIN Calcium Tablets 10mg x 90 2441567 90's Bottle 63304-827-90 31-Aug-14 ATORVASTATIN Calcium Tablets 10mg x 90 2441568 90's Bottle 63304-827-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2436731 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2437381 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2437940 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2437942 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2437945 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2437947 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2437952 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2437953 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2437960 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2440676 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2440677 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2440680 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 20mg x 90 2440681 90's Bottle 63304-828-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 500 2437956 500's Bottle 63304-829-05 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 500 2437957 500's Bottle 63304-829-05 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 500 2440675 500's Bottle 63304-829-05 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2434265 90's Bottle 63304-829-90 31-Jul-14 ATORVASTATIN Calcium Tablets 40mg x 90 2434266 90's Bottle 63304-829-90 31-Jul-14 ATORVASTATIN Calcium Tablets 40mg x 90 2434824 90's Bottle 63304-829-90 31-Jul-14 ATORVASTATIN Calcium Tablets 40mg x 90 2434826 90's Bottle 63304-829-90 31-Jul-14 ATORVASTATIN Calcium Tablets 40mg x 90 2434827 90's Bottle 63304-829-90 31-Jul-14
ATORVASTATIN Calcium Tablets 40mg x 90 2434828 90's Bottle 63304-829-90 31-Jul-14 ATORVASTATIN Calcium Tablets 40mg x 90 2434829 90's Bottle 63304-829-90 31-Jul-14 ATORVASTATIN Calcium Tablets 40mg x 90 2434830 90's Bottle 63304-829-90 31-Jul-14 ATORVASTATIN Calcium Tablets 40mg x 90 2434831 90's Bottle 63304-829-90 31-Jul-14 ATORVASTATIN Calcium Tablets 40mg x 90 2436580 90's Bottle 63304-829-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2436725 90's Bottle 63304-829-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2436727 90's Bottle 63304-829-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2436729 90's Bottle 63304-829-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2437377 90's Bottle 63304-829-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2437380 90's Bottle 63304-829-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2437941 90's Bottle 63304-829-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2437943 90's Bottle 63304-829-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2437944 90's Bottle 63304-829-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2437949 90's Bottle 63304-829-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2437950 90's Bottle 63304-829-90 31-Aug-14 ATORVASTATIN Calcium Tablets 40mg x 90 2437955 90's Bottle 63304-829-90 31-Aug-14
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SOURCES:
News release, FDA.
FDA web site.
Department of Justice web site.
Ranbaxy web site.
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Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is near optimal.
Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is borderline high. If your LDL goes higher, your total cholesterol level could become Borderline High. Consider reducing the amount of foods you eat with saturated fats and increasing physical activity. If you get more exercise, your level of "good" HDL cholesterol may increase, which could also help to keep your levels of LDL and total cholesterol in check.
Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL. The HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.
Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is Very High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL because the HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.
Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.
Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.
Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is Borderline High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!
Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!
Your total cholesterol level is Borderline High. But your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!
Your total cholesterol is High, but your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.
Your total cholesterol is High, but your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.
Your total cholesterol level is High. Your level of "bad" LDL cholesterol is Borderline High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!
Your total cholesterol level is High. Your level of "bad" LDL cholesterol is High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe medication, such as statins. Following medication, dietary, and exercise instructions should result in improvements.
Your total cholesterol level is High, and your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe statins or other cholesterol-lowering medications.
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