FDA-Drug2019-01-30Class II

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

Dr. Reddy's Laboratories, Inc.
Hazard

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

Sold states
Nationwide within the United States
Affected count
118 bottles
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
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. Princeton, NJ 08540 USA, NDC 43598-586-10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2019

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