FDAClass IIMarch 20, 2024

Febuxostat Tablets 80mg recall: CGMP Deviations

Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun…

Why was Febuxostat Tablets 80mg recalled?

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: DNE0894A, Exp 07/31/2025

Product
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun…
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Quantity
7,488 bottles
Distribution
Nationwide
Recall date
March 20, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls