Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 277
Summary
The FDA issued a Class II for Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: by Accord Healthcare, Inc.. Reason: CGMP Deviations: recalling drug products following an FDA inspection..
Details
Source
Drug Recall
External ID
D-0419-2023
Action Date
2023-03-08
Status
Terminated
Category
drug
Product 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.
Lot/Code Info: Batches: P2202518, P2202512, Exp. Date 4/30/2024, P2204588, P2204589, Exp. Date 7/31/2024
Quantity Affected: 2614 cartons
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Distribution
United States including Puerto Rico and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-07
Company
Durham, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 123 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Accord Healthcare, Inc. has 90 FDA actions in our database, including 90 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Accord Healthcare, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Accord Healthcare, Inc. have FDA actions?
Accord Healthcare, Inc. has 90 FDA actions in our database, including 90 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0419-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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