The biggest two recalls of Simvastatin happened between and and involved 5, to 54, bottles each. So far there have been no incidents in There were a few other relatively minor recalls less than about 1, bottles each , with one also from Micro Labs USA. One somewhat confusing recall of the drug came from Attix Pharmaceuticals.
For a more comprehensive view, see the sections below. Dozens of companies make Simvastatin. It includes multiple recall numbers for a few of the major recalls listed above. It also gives detail on the smaller recalls, affecting less than 1, bottles each. Simvastatin recalls are grouped by an FDA class number. Class I Recall. This is very rare. Class II Recall. Half the recalls listed in this reference are Class II. This FDA recall-type is preventative in nature. Class III Recall. This is the least serious FDA recall category.
Half the recalls shown below are Class III. The FDA identifies recalls by three different dates: issue date , classification date, and termination date.
The first date is the issue date and the second is the classification date. The list above gives the top-level data on the ten total Simvastatin recalls through , including three major recalls and several minor ones.
The next biggest confirmed recall affected Biocon, Inc. Drug recalls can be expensive. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
No Duty to Update The information contained in this website was current as of the date presented. Take simvastatin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
Take simvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you will be taking the simvastatin suspension, do not use a household teaspoon to measure your dose. Household teaspoons are not accurate measuring devices, and you may receive too much medication or not enough medication if you measure your dose with a household teaspoon. Instead, use a properly marked measuring device such as a medicine spoon or oral syringe.
Ask your doctor or pharmacist if you need help getting or using a measuring device. Your doctor may start you on a low dose of simvastatin and gradually increase your dose, not more than once every 4 weeks. Continue to take simvastatin even if you feel well. Do not stop taking simvastatin without talking to your doctor. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Eat a low-fat, low-cholesterol diet.
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue the regular dosing schedule. Do not take a double dose to make up for a missed one. This medication may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture not in the bathroom. Store the suspension at room temperature. Do not freeze or refrigerate the suspension. Be sure to use the suspension within 30 days of opening the bottle and discard any remaining medication after 30 days.
It is important to keep all medication out of sight and reach of children as many containers such as weekly pill minders and those for eye drops, creams, patches, and inhalers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them.
However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. In case of overdose, call the poison control helpline at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at Keep all appointments with your doctor and the laboratory.
Your doctor may order certain lab tests during your treatment, especially if you develop symptoms of liver damage.
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