D-0368-2024Class II

SUN PHARMACEUTICAL INDUSTRIES INC

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-03-20

Distribution

Nationwide

Firm state

Product quantity

47,520 bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

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

Product description

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.

Code / lot info

Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025

Other recalls SPEQ maps to Environmental Monitoring

2026-07-22Class IArgon Medical Devices, Inc 2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC 2026-07-22Class IIOlympus Corporation of the Americas

See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.