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
Recall Number: D-0389-2019
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class II
Status: Terminated
Report Date: 20190130
Initiation Date: 20190115
Termination Date: 20200303
Reason for Recall
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Product Description
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