Drug & medication recalls Moderate risk

Dr. Reddy's Laboratories, Inc. recalls Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. L…

Recall date
January 15, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0389-2019
FDA classification
Class II
Brand / firm
Dr. Reddy's Laboratories, Inc.
Sold / distributed
Nationwide within the United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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

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