Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.
Reason
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Classification
Class II
Status
Completed
Lot
Lot #s: DNE0866B Exp. 06/30/2025, DNE1045A, DNE1046B Exp. 08/31/2025
Date
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