FDA recall D-0368-2024

SUN PHARMACEUTICAL INDUSTRIES INC · Class II · drug

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 for recall

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

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2024-03-04
Report date
2024-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0368-2024