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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot number: L013425, Exp. 11/2016
Where it was sold
KY, MS and OH.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0007-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 14, 2015
- FDA report date
- Oct 14, 2015
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Merck Sharp & Dohme, Wilson Facility
Original FDA data
Every field from FDA enforcement report D-0007-2016, exactly as published.
Show all FDA fields
- City
- Wilson
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 72324
- Address
- 4633 Merck Rd W
- Code information
- Lot number: L013425, Exp. 11/2016
- Postal code
- 27893-9613
- Report date
- Oct 14, 2015
- Product type
- Drugs
- Recall number
- D-0007-2016
- Classification
- Class II
- Recalling firm
- Merck Sharp & Dohme, Wilson Facility
- Termination date
- May 4, 2016
- Reason for recall
- Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- KY, MS and OH.
- Recall initiation date
- Aug 14, 2015
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2015