ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0511-2023
Description: Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9
ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0511-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0511-2023 |
| Event ID | 91952 |
| Brand | ATORVASTATIN CALCIUM |
| Generic Name | ATORVASTATIN CALCIUM |
| Manufacturer | ATORVASTATIN CALCIUM |
| Active Substance | ATORVASTATIN CALCIUM TRIHYDRATE |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 158 Bottles |
| Recall Reason | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230412 |
| Product NDC | 68788-7630 68788-7631 |
| 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 | 48A5M73Z4Q |
| Drug Application Number | ANDA207687 |
| Structured Product Labeling (SPL ID) | 9306c3e0-a260-4d70-9d65-e821a561492d |
| Structured Product Labeling (SPL Set ID) | bdd60262-8382-46c1-b15a-6bc345d67b65 |
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