ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0371-2023
Description: Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA.
ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0371-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0371-2023 |
| Event ID | 91657 |
| Brand | ATORVASTATIN CALCIUM |
| Generic Name | ATORVASTATIN CALCIUM |
| Manufacturer | ATORVASTATIN CALCIUM |
| Original Package? | 1 |
| Active Substance | ATORVASTATIN CALCIUM TRIHYDRATE |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 256,106 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-044 16729-045 16729-046 |
| Drug UPC | 316729044158 316729044172 |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 48A5M73Z4Q |
| Drug Application Number | ANDA207687 |
| Structured Product Labeling (SPL ID) | c724ae44-1c23-e3c9-e053-2a95a90a5c79 |
| Structured Product Labeling (SPL Set ID) | 4e06b20d-cc5d-46eb-991b-5972248de3af |
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