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Recall Observatory FDA recall evidence

Drug product

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

D-1312-2014

January 13, 2014

Class III

Product summary

Firm
Merck & Co Inc
Event
Event 67344
Status
Terminated
Classification
Class III
Quantity
11,462 cartons
Official record key
drug-enforcement:D-1312-2014

Official wording

Reason: 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.

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.

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.