Class III · Low risk
Ezetimibe and Simvastatin Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Liptruzet (ezetimibe and atorvastin)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
This recall of LIPTRUZET is being initiated due to packaging defects. 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.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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
Affected NDCs
66582-0320-30
66582-0320-54
Compare with the code on your package — it is the most precise check available.
Drug: Ezetimibe Category: Cholesterol Medication
- Recalling firm
- Merck & Co Inc
- NDC code
- 66582-320-30
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1309-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ezetimibe recalls
See all
Class III · Low risk
NEXLIZET (bempedoic acid and ezetimibe)
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Class III · Low risk
Nexlizet (bempedoic acid and ezetimibe)
Failed dissolution specifications: below specification results at stability 12-month
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Other recalls by Merck & Co Inc
All 2014 recalls
Class II · Moderate risk
Belsomra (suvorexant)
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
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.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
This recall of LIPTRUZET is being initiated due to packaging defects. 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.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
This recall of LIPTRUZET is being initiated due to packaging defects. 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.
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