ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0548-2023
Description: Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52
ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0548-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0548-2023 |
| Event ID | 91944 |
| Brand | ATORVASTATIN CALCIUM |
| Generic Name | ATORVASTATIN CALCIUM |
| Manufacturer | ATORVASTATIN CALCIUM |
| Active Substance | ATORVASTATIN CALCIUM TRIHYDRATE |
| Drug Route | ORAL |
| Distribution | Nationwide with the United States |
| Quantity | 99 bottles |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20230503 |
| Product NDC | 51655-946 |
| Recall Initiation Date | 20230316 |
| Report Date | 20230503 |
| Classification Date | 20230426 |
| Address | 4838 Fletcher Ave Ste 1000 Indianapolis, IN 46203-1642 United States |
| Recalling Firm | Northwind Pharmaceuticals LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | 48A5M73Z4Q |
| Drug Application Number | ANDA207687 |
| Structured Product Labeling (SPL ID) | df6234ab-65db-3e43-e053-2a95a90a0287 |
| Structured Product Labeling (SPL Set ID) | df6233cf-5b4e-5fbe-e053-2a95a90a0a80 |
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