D-0389-2019 Class II Terminated
FDA drug recall D-0389-2019 was initiated by Dr. Reddy's Laboratories, Inc. on January 15, 2019 and is designated Class II. Reason for recall: Presence of Foreign Substance: Product complaint of black speckles observed on tablets. The recall status is terminated (terminated March 3, 2020). Affected quantity: 118 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 30, 2019
- Initiation Date
- January 15, 2019
- Termination Date
- March 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118 bottles
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
Reason for Recall
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 43E021 and 43E023, Exp. 01/2020