Product Safety Recalls

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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

Mandated?Voluntary: Firm initiated
Recall NumberD-0420-2023
Event ID91657
Original Package?1
Active SubstancePIRFENIDONE
Drug RouteORAL
DistributionUnited States including Puerto Rico and Canada
Quantity2641 bottles
Recall ReasonCGMP Deviations: recalling drug products following an FDA inspection.
Drug ClassificationClass II
Drug Code Info20230308
Product NDC16729-467 16729-468
Product NUIN0000191420 M0018236
Drug UPC316729468152
Pharma Class (EPC)Pyridone [EPC]
Pharma Class (CS)Pyridones [CS]
Recall Initiation Date20230207
Report Date20230308
Classification Date20230302
Address1009 Slater Rd Ste 210B
Durham, NC 27703-8446
United States
Recalling FirmAccord Healthcare, Inc.
Initial Notification Letter
Unique Ingredient IdentifierD7NLD2JX7U
Drug Application NumberANDA212730
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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