Recall archive / FDA drug enforcement
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories ... — FDA record D-0228-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 14, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Quantity
- 49
- Agency-reported status
- Terminated
- Source record identifier
- D-0228-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GS040048, Exp: 1/2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed to two distributors located in AZ and MO
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 17, 2021
- Recall initiation date
- Oct 14, 2021
- Center classification date
- Nov 9, 2021
- Termination date
- Nov 10, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.