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FDARecalled Jan 31, 2024 · #D-0264-2024

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...

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Classification: Class II Distribution: Nationwide in the USA

Product details

Product
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.
Type
Drugs
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Model numbers
UPCs