FDA Drug recall D-0419-2023
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by:…
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by:… by Accord Healthcare, citing CGMP Deviations: recalling drug products following an FDA inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0419-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-07 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | PR |
Product
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.
Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Identifiers
| upc | 316729467155 |
|---|---|
| upc | 316729467858 |
| ndc | 16729-468-15 |
| ndc | 16729-468-64 |
| ndc | 16729-467-15 |
| ndc | 16729-467-85 |
| ndc | 16729-467-64 |
| code_info | Batches: P2202518, P2202512, Exp. Date 4/30/2024, P2204588, P2204589, Exp. Date 7/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0419-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.