FDA Drug recall D-0227-2022
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shre…
- FDA Drug
- Class II
- terminated
- Published 2021-11-17
On 2021-11-17 the FDA classified a Class II recall of Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shre… by Golden State Medical Supply, citing failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastat….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0227-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-14 |
| Published | 2021-11-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Golden State Medical Supply |
| Distribution | AZ, MO |
Product
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05
Reason
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Identifiers
| ndc | 51407-190-30 |
|---|---|
| ndc | 51407-190-90 |
| ndc | 51407-190-10 |
| ndc | 51407-191-30 |
| ndc | 51407-191-90 |
| ndc | 51407-191-10 |
| ndc | 51407-192-30 |
| ndc | 51407-192-90 |
| ndc | 51407-192-05 |
| ndc | 51407-192-10 |
| ndc | 51407-193-30 |
| ndc | 51407-193-90 |
| ndc | 51407-193-05 |
| code_info | a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0227-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.