Merck Recalls Vytorin Tablets Due to Foreign Tablet Presence
Merck Sharp & Dohme is recalling specific bottles of Vytorin 10 mg/20 mg tablets because they contain 10 mg/40 mg tablets. The recall affects distribution in Kentucky, Mississippi, and Ohio.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential dosing errors or significant injury risks, even if specific hospitalizations are not explicitly detailed in the brief source text.
Plain-English summary
Merck Sharp & Dohme, Wilson Facility, is recalling Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, 1000 count bottles. The recall is due to the presence of foreign tablets; specifically, Vytorin 10 mg/40 mg tablets were found in bottles labeled as 10 mg/20 mg tablets.
The affected product is identified by Lot number L013425 with an expiration date of 11/2016. The NDC number for the recalled product is 66582-0312-82. The recall is limited to distribution in Kentucky, Mississippi, and Ohio.
Consumers who have this specific lot of Vytorin should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA classifies this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only, 1000 count Bottle, Manuf. For Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, NDC 66582-0312-82.
- Manufacturer
- Merck Sharp & Dohme, Wilson Facility
- Category
- Drug — Prescription Medication
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 (2)
- Lot number: L013425
- Exp. 11/2016
Distribution
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