D-1311-2014 Class III Terminated
FDA drug recall D-1311-2014 was initiated by Merck & Co Inc on Jan 13, 2014 and is designated Class III. Reason for recall: This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change… The recall status is terminated (terminated Sep 2, 2015). Affected quantity: 36,493 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
- 36,493 cartons
Product Description
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Reason for Recall
This recall of LIPTRUZET is being initiated due to packaging defects. 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 10/40mg 30 count, 346304, 346342, 350256, 353107, 353108, 353109, Exp. 06/14; 353110, Exp.12/14 b) Liptruzet 10/40mg 90 count 346382, Exp. 06/14; 353186, Exp.12/14.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1311-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026