The Recall Desk
LowFDA (Drugs)·D-1312-2014·Announced 2014-05-14

Merck Recalls Liptruzet Tablets Due to Defective Outer Packaging

Merck is recalling Liptruzet tablets because defective outer foil pouches may allow air and moisture to enter, potentially affecting product effectiveness.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is limited to potential loss of effectiveness due to packaging defects.

Plain-English summary

Merck & Co. is recalling 11,462 cartons of Liptruzet (ezetimibe and atorvastin) tablets, 10 mg/80 mg. The recall involves 30-count and 90-count blister packs distributed nationwide and in Puerto Rico.

The recall is due to defective outer laminate foil pouches that allowed air and moisture to enter. This defect could potentially decrease the effectiveness or change the characteristics of the product.

Patients and consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled items, they should contact their healthcare provider or pharmacist for guidance on replacement or discontinuation.

The recalled product

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
Manufacturer
Merck & Co Inc
Category
Drug — Prescription Medication
Hazard
Affected units
11,462

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • 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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Merck & Co Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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Same hazard · packaging defect

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