Febuxostat Tablets 80mg, 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 16714-060-01

FDA recall notice · announced March 20, 2024 · Sun Pharmaceutical Industries

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Febuxostat Tablets 80mg, 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 16714-060-01.

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot #: DNE0894A, Exp 07/31/2025
Quantity: 7,488 bottles
Status: Ongoing
Products in this recall event:
- 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, (D-0368-2024)
- Febuxostat Tablets 80mg, 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, D (D-0369-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.