FDA Drug Class II — Moderate

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

Hazard

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

Products

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. P
Brand
Dr. Reddy's Laboratories, Inc.
UPC
Lot #: 43E021 and 43E023, Exp. 01/2020

Units Affected

118 bottles