Recalls / Class II
Class IID-0228-2022
Product
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05
- Brand name
- Ezetimibe And Simvastatin
- Generic name
- Ezetimibe And Simvastatin
- Active ingredients
- Ezetimibe, Simvastatin
- Route
- Oral
- NDCs
- 51407-190, 51407-191, 51407-192, 51407-193
- FDA application
- ANDA200909
- Affected lot / code info
- GS040048, Exp: 1/2023
Why it was recalled
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Manufacturer
- Golden State Medical Supply, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- 49
- Distribution pattern
- Distributed to two distributors located in AZ and MO
Timeline
- Recall initiated
- 2021-10-14
- FDA classified
- 2021-11-09
- Posted by FDA
- 2021-11-17
- Terminated
- 2022-11-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0228-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.