FDA Recall D-0368-2024

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class II Ongoing 801 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

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

Quantity: 47,520 bottles

Reason for recall

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

Recall record

Recall number: D-0368-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2024-03-04
Classified by FDA Center: 2024-03-08
FDA published: 2024-03-20
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Firm location: Princeton, NJ

Drug identification

Brand name(s): FEBUXOSTAT
Generic name(s): FEBUXOSTAT
Manufacturer(s): NorthStar RxLLC
NDC(s): 16714-059, 16714-060
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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