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Recall Observatory FDA recall evidence

Drug product

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

D-1311-2014

January 13, 2014

Class III

Product summary

Firm
Merck & Co Inc
Event
Event 67344
Status
Terminated
Classification
Class III
Quantity
36,493 cartons
Official record key
drug-enforcement:D-1311-2014

Official wording

Reason: 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.

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.

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.