Drug product
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.
D-0007-2016
Product summary
- Event
- Event 72324
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0007-2016
Official wording
Reason: Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Code information: Lot number: L013425, Exp. 11/2016
Distribution pattern: KY, MS and OH.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet