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
D-0389-2019
Product summary
- Event
- Event 81936
- Status
- Terminated
- Classification
- Class II
- Quantity
- 118 bottles
- Official record key
drug-enforcement:D-0389-2019
Official wording
Reason: Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Code information: Lot #: 43E021 and 43E023, Exp. 01/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance