Class III · Low risk
Ezetimibe and Simvastatin Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Vytorin (ezetimibe and simvastatin)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only, 1000 count Bottle, Manuf. For Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, NDC 66582-0312-82.
Affected NDC
66582-0312-82
Compare with the code on your package — it is the most precise check available.
Drug: Simvastatin Category: Cholesterol Medication
- Recalling firm
- Merck Sharp & Dohme, Wilson Facility
- NDC code
- 66582-0312-82
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0007-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Simvastatin recalls
See all
Class II · Moderate risk
Simvastatin USP 40 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP 20 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP
CGMP deviations.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Other particulate / foreign matter recalls from 2015
All particulate / foreign matter recalls
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.125 mg
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class II · Moderate risk
Baclofen USP powder
Presence of Foreign Substance
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