ROSUVASTATIN CALCIUM Recall D-0520-2023
Description: Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
ROSUVASTATIN CALCIUM Recall D-0520-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0520-2023 |
| Event ID | 91952 |
| Brand | ROSUVASTATIN |
| Generic Name | ROSUVASTATIN |
| Manufacturer | ROSUVASTATIN |
| Active Substance | ROSUVASTATIN CALCIUM |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 264 Bottles |
| Recall Reason | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230412 |
| Product NDC | 68788-7971 |
| 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 | 83MVU38M7Q |
| Drug Application Number | ANDA206434 |
| Structured Product Labeling (SPL ID) | 7014a4df-8c38-4de7-87a3-8d35fe26fcc1 |
| Structured Product Labeling (SPL Set ID) | 91a65d8e-68bc-4b0c-be39-0bffab33fb04 |
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