Merck Recalls Liptruzet Tablets Due to Packaging Defects
Merck & Co. is recalling Liptruzet tablets because packaging defects allowed air and moisture to enter, potentially affecting product effectiveness.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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, with no reported injuries or illnesses.
Plain-English summary
Merck & Co. is recalling Liptruzet (ezetimibe and atorvastin) tablets, 10 mg/10 mg, due to packaging defects. The recall involves 11,175 cartons of the medication, which was 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 product or change its characteristics.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment. The affected products 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/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
- Manufacturer
- Merck & Co Inc
- Category
- Drug — Prescription Medication
- Affected units
- 11,175
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 (10)
- a) Liptruzet 10/10mg
- 30 count
- 346380
- 353183
- Exp. 07/14 b) Liptruzet 10/10mg
- 90 count 346381
- 350264
- Exp 07/14
- 357235
- Exp. 12/14.
Distribution
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 →Related recalls
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- LowMerck Recalls Liptruzet Tablets Due to Packaging Defects
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- LowMerck Recalls Liptruzet Tablets Due to Defective Outer Packaging
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