1. Home
  2. Labeler Index
  3. Northstar Rxllc
  4. 16714-059
  5. FDA Recall: Febuxostat

FDA Recall Febuxostat

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Febuxostat with NDC 16714-059 was initiated on 03-04-2024 as a Class II recall due to cgmp deviations: microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. The latest recall number for this product is D-0369-2024 and the recall is currently ongoing .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0369-202403-04-202403-20-2024Class II7,488 bottlesFebuxostat 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.Ongoing
D-0368-202403-04-202403-20-2024Class II47,520 bottlesFebuxostat 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.Ongoing

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.