Drug product
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05
D-0085-2022
Product summary
- Event
- Event 88798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 696 bottles
- Official record key
drug-enforcement:D-0085-2022
Official wording
Reason: Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Code information: L100208, exp 01/2023
Distribution pattern: Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets