Drug recall D-0082-2022
Product
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) 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
Reason for recall
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Lots and codes
a) L100298 and L100304, exp 01/2023 b) L100235, exp 01/2023
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- a) 30,839 bottles, b) 3,830 bottles
- Distribution
- Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 5, 2021
- Terminated
- February 16, 2023
Related products
- Ezetimibe and simvastatin – drug information
- NDC 43598-745 Ezetimibe and Simvastatin · Ezetimibe 10 mg/1; Simvastatin 80 mg/1 · Dr.Reddys Laboratories Inc
- NDC 43598-744 Ezetimibe and Simvastatin · Ezetimibe 10 mg/1; Simvastatin 20 mg/1 · Dr.Reddys Laboratories Inc
- NDC 43598-743 Ezetimibe and Simvastatin · Ezetimibe 10 mg/1; Simvastatin 40 mg/1 · Dr.Reddys Laboratories Inc
- NDC 43598-742 Ezetimibe and Simvastatin · Ezetimibe 10 mg/1; Simvastatin 10 mg/1 · Dr.Reddys Laboratories Inc