SIMVASTATIN Recall D-0523-2023
Description: Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
SIMVASTATIN Recall D-0523-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0523-2023 |
| Event ID | 91952 |
| Brand | SIMVASTATIN |
| Generic Name | SIMVASTATIN |
| Manufacturer | SIMVASTATIN |
| Active Substance | SIMVASTATIN |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 57 Bottles |
| Recall Reason | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230412 |
| Product NDC | 68788-9429 68788-9747 68788-9869 |
| Product NUI | N0000175589 N0000000121 |
| Pharma Class (EPC) | HMG-CoA Reductase Inhibitor [EPC] |
| Recall Initiation Date | 20230323 |
| Report Date | 20230412 |
| Classification Date | 20230406 |
| Address | 1250 N Lakeview Ave Ste O Anaheim, CA 92807-1801 United States |
| Recalling Firm | Preferred Pharmaceuticals, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | AGG2FN16EV |
| Drug Application Number | ANDA078155 |
| Structured Product Labeling (SPL ID) | a6a377c0-6795-4d61-8c65-678cfdf04aaf |
| Structured Product Labeling (SPL Set ID) | 7442f35f-74e8-4c35-9666-190a3baad549 |
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