PIRFENIDONE Recall D-0419-2023
Description: Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 16729-467-15, UPC 3 16729 46715 5; Carton NDC 16729-467-85, UPC 3 16729 46785 8.
PIRFENIDONE Recall D-0419-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0419-2023 |
| Event ID | 91657 |
| Brand | PIRFENIDONE |
| Generic Name | PIRFENIDONE |
| Manufacturer | PIRFENIDONE |
| Original Package? | 1 |
| Active Substance | PIRFENIDONE |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 2614 cartons |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-467 16729-468 |
| Product NUI | N0000191420 M0018236 |
| Drug UPC | 316729467155 316729467858 |
| Pharma Class (EPC) | Pyridone [EPC] |
| Pharma Class (CS) | Pyridones [CS] |
| 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 | D7NLD2JX7U |
| Drug Application Number | ANDA212730 |
| Structured Product Labeling (SPL ID) | ee1fd8c9-98f3-7da3-e053-2995a90a6b78 |
| Structured Product Labeling (SPL Set ID) | fab59395-1c5d-4c64-ba47-34d75736e983 |
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