SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38
Recalled March 20, 2024 · FDA recall D-0369-2024 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. · FDA Class II
Units
7,488 bottles
Sold at
Nationwide
Description
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Product
Febuxostat Tablets 80mg, 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 16714-060-01.
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →