Why it was recalled
Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Product description
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Lot numbers, UPCs & expiration codes
a) Liptruzet 10/80mg 30 count, 346379, 350257, Exp.07/14; 353591, Exp. 06/15. b) Liptruzet 10/80mg 90 count, 346383, 371072, Exp. 06/15.
Where it was sold
Nationwide and Puerto Rico
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-1312-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 13, 2014
- FDA report date
- May 14, 2014
- Quantity
- 11,462 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Merck & Co Inc
Original FDA data
Every field from FDA enforcement report D-1312-2014, exactly as published.
Show all FDA fields
- City
- Whitehouse Station
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67344
- Address
- 1 Merck Dr
- Address (line 2)
- P.O. Box 100
- Code information
- a) Liptruzet 10/80mg 30 count, 346379, 350257, Exp.07/14; 353591, Exp. 06/15. b) Liptruzet 10/80mg 90 count, 346383, 371072, Exp. 06/15.
- Postal code
- 08889-3400
- Report date
- May 14, 2014
- Product type
- Drugs
- Recall number
- D-1312-2014
- Classification
- Class III
- Recalling firm
- Merck & Co Inc
- Product quantity
- 11,462 cartons
- Termination date
- Sep 2, 2015
- Reason for recall
- Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jan 13, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 6, 2014