The Recall Desk
LowFDA (Drugs)·D-1311-2014·Announced 2014-05-14

Merck Recalls Liptruzet Tablets Due to Packaging Defects

Merck is recalling Liptruzet tablets because outer packaging defects allowed 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 and involves packaging defects that may affect product effectiveness, which the rubric defines as typically low severity with no reported injuries.

Plain-English summary

Merck & Co. is recalling specific lots of Liptruzet (ezetimibe and atorvastatin) tablets, 10 mg/40 mg, due to packaging defects. The recall involves 30-count and 90-count blister packs distributed nationwide and in Puerto Rico.

The recall was initiated because some of the outer laminate foil pouches allowed air and moisture to enter. This exposure could potentially decrease the effectiveness of the medication or change its characteristics.

Consumers with these specific products should contact their healthcare provider or pharmacist for guidance. The affected lots are identified by specific expiration dates and lot numbers listed in the recall documentation.

The recalled product

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
Manufacturer
Merck & Co Inc
Category
Drug — Prescription Medication
Hazard
Affected units
36,493

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 (12)

  • 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
  • 353186
  • Exp.12/14.

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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