Recall: D-0368-2024

Class II - Potentially Harmful

Class IIClassification

2024-03-04Initiated

OngoingStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

Product

Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.

Reason

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.