ROSUVASTATIN CALCIUM Recall D-0406-2023
Description: Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
ROSUVASTATIN CALCIUM Recall D-0406-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0406-2023 |
| Event ID | 91657 |
| Brand | ROSUVASTATIN |
| Generic Name | ROSUVASTATIN |
| Manufacturer | ROSUVASTATIN |
| Original Package? | 1 |
| Active Substance | ROSUVASTATIN CALCIUM |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 43,302 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-284 16729-285 16729-286 |
| Drug UPC | 316729286152 316729286176 |
| 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 | 83MVU38M7Q |
| Drug Application Number | ANDA206434 |
| Structured Product Labeling (SPL ID) | d3ccd580-36de-5396-e053-2995a90a7403 |
| Structured Product Labeling (SPL Set ID) | 3ffe0294-3997-2755-e054-00144ff8d46c |
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