PIRFENIDONE Recall D-0420-2023
Description: Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-468-15, UPC 3 16729 46815 2.
PIRFENIDONE Recall D-0420-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0420-2023 |
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 | 2641 bottles |
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 | 316729468152 |
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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