The Recall Desk
LowFDA (Drugs)·D-1310-2014·Announced 2014-05-14

Merck Recalls Liptruzet Tablets Due to Packaging Defects

Merck & Co. is recalling Liptruzet tablets because packaging defects allowed air and moisture to enter, potentially reducing 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 by definition is unlikely to cause adverse health consequences. The hazard is limited to packaging defects that may affect product effectiveness rather than causing direct injury.

Plain-English summary

Merck & Co. is recalling specific lots of Liptruzet (ezetimibe and atorvastin) tablets, 10 mg/20 mg. The recall involves 20,259 cartons of the 30-count and 90-count blister packs distributed nationwide and in Puerto Rico.

The recall was initiated due to packaging defects where some 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 stop using them and contact their healthcare provider or pharmacist for guidance. The affected lots are identified by specific lot numbers and expiration dates listed in the recall notice.

The recalled product

Product
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), 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
20,259

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 10/20mg 30 count
  • 346353
  • 346354
  • Exp. 06/14
  • 351809
  • Exp. 07/14
  • 360530
  • Exp. 12/14. b) Liptruzet 10/20mg
  • 90 count
  • 346387
  • 353185
  • 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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