Is simvastatin being recalled?
Is simvastatin being recalled?
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.
What statin drugs have been recalled?
The recall includes 90-count bottles of atorvastatin calcium tablets, 10 mg (NDC 70377-027-11), from lot ATA318099C (Exp. 12/20). The tablets were manufactured by Graviti Pharmaceuticals for Biocon Pharma and distributed throughout the United States.
Is there a problem with simvastatin?
While statins are highly effective and safe for most people, they have been linked to muscle pain, digestive problems and mental fuzziness in some people who take them and may rarely cause liver damage.
Why has simvastatin been recalled?
Simvastatin Recall: The biggest recall was the 2015 Class III recall by Micro Labs, involving 54,096 bottles. The reason for the Simvastatin Recall was impurities in the pills.
Where is simvastatin manufactured?
China
Most of the North American supply of aspirin, for example, comes from China, which produces about 120 billion tablets per year. Other widely used drugs, such as omeprazole and simvastatin often come from Puerto Rico and India.
What drug company makes simvastatin?
ZOCOR® (simvastatin) – Merck.com.
Are statins bad for you 2021?
TUESDAY, Oct. 5, 2021 (HealthDay News) — Statins are proven to lower cholesterol, but they may also come with a downside for patients with diabetes: A new study finds they may make the blood sugar disease worse.
How many bottles of simvastatin have been recalled?
The biggest Simvastatin recall so far affected just over 54,000 bottles, which is relatively minor compared to other generic medications. (Lisinopril had over a million bottles recalled at once.) The biggest recall was the 2015 Class III recall by Micro Labs, involving 54,096 bottles.
What are the side effects of simvastatin 80mg?
Patients taking Zocor who experience muscle pain or tenderness, fatigue, weakness, or dark urine should seek immediate medical attention. Taking the 80mg dose of Simvastatin (the highest approved dose)have been found to be at greater risk for severe side effects, especially during the first year of treatment.
How to report an adverse event with simvastatin?
Switch patients who need to be initiated on a drug that interacts with simvastatin to an alternative statin with less potential for the drug-drug interaction. Report adverse events involving simvastatin-containing medicines to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of this page.
What’s the generic name for the drug simvastatin?
Simvastatin. Generic Name: simvastatin (SIM va sta tin) Brand Name: Zocor. Medically reviewed by Sanjai Sinha, MD. Last updated on Nov 2, 2020. Uses. Warnings. Dosage. What to avoid.
