D-1312-2014 Class III Terminated
FDA drug recall D-1312-2014 was initiated by Merck & Co Inc on Jan 13, 2014 and is designated Class III. 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. The recall status is terminated (terminated Sep 2, 2015). Affected quantity: 11,462 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- May 14, 2014
- Initiation Date
- Jan 13, 2014
- Termination Date
- Sep 2, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,462 cartons
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
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.
Distribution Pattern
Nationwide and Puerto Rico
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1312-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026