FDA recall D-0389-2019

Dr. Reddy's Laboratories, Inc. · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2019-01-15
Report date: 2019-01-30
Termination date: 2020-03-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

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