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
Reported: November 10, 2021 Initiated: October 5, 2021 #D-0082-2022
Product Description
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
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- a) 30,839 bottles, b) 3,830 bottles
- Distribution
- Nationwide in the US
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: a) 30,839 bottles, b) 3,830 bottles.
Why was this product recalled? ▼
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 10, 2021. Severity: Moderate. Recall number: D-0082-2022.
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