FDA-Drug2024-03-20Class II
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.
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sold states
Nationwide
Affected count
47,520 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0368-2024Don't want to check this manually?
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