US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jan 15, 2019 (8 years ago)

Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Substance: Product complaint of black speckles observed on tablets.

What was recalled

Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10

Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
43598-586-10
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0389-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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