Recalls / Class II
Class IID-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
- Brand name
- Ezetimibe And Simvastatin
- Generic name
- Ezetimibe And Simvastatin
- Active ingredients
- Ezetimibe, Simvastatin
- Route
- Oral
- NDCs
- 43598-742, 43598-744, 43598-743, 43598-745
- FDA application
- ANDA200909
- Affected lot / code info
- a) L100298 and L100304, exp 01/2023 b) L100235, exp 01/2023
Why it was recalled
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddys Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- a) 30,839 bottles, b) 3,830 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-10-05
- FDA classified
- 2021-10-29
- Posted by FDA
- 2021-11-10
- Terminated
- 2023-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0082-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.